The Nanox.Arc tomosynthesis demoed at RSNA2020 looks fake.
It was likely prepared in advance elsewhere. Inspecting the image orientation of DICOM thumbnails shows a 180° mismatch for the lamb femur in the reconstructed image:
January 07, 2021
January 06, 2021
Nanox mission
Not to be confused with Nanox vision (announced in a press release with SKT in June 2019), Nanox mission is:
“to replace all legacy sources with our digital X-ray.” (November 2019 press release)
 |
| From/To in Nanox November 2019 press release |
Yes, that digital X-Ray source has a field of nano-gates (that is, holes) that emit pixie dust (because electrons are emitted by nano-cones, not nano-holes) in discrete streams instead of a Schrödinger cloud, according to the illustration above. And cathodes, anodes, and years do not matter (based on the From half).
Unfortunately, Nanox own facilitator and option holder testifies that nobody wanted that non-existent digital X-ray source. Not even when the current CEO, then the Chief Strategy Officer of Nanox predecessor, went to RSNA 2015 to show it around. Now the title of his blog is IMAGING 3.0 which is remarkably similar to Imaging3. Coincidence or Freudian slip? No way he did not know about Imaging3.
January 05, 2021
To the best of Nanox knowledge
Nanox (and predecessor) "first" press releases are quite amusing - Singapore detector in October 2013, digital 1x1x1 in June 2019, and the field of cones, November 2019.
So, Mr. Masuya, a lawyer and the founder and CEO of Nanox predecessor, says in November 2019:
to the best of our knowledge no company have achieved a commercially stable [cold cathode] source [based on carbon nano tubes] that can be embedded inside a medical imaging system and operate with an acceptable lifespan.
The problem is that he must have known that Carestream and Micro-X had received clearance for and commercialized their Nano x-ray system with a cold-cathode source based on carbon nano tubes in February 2018. That source was initially made by XinRay (a Siemens JV now defunct, but see NuRay), and now by Micro-X Ltd. So much for Nanox "knowledge."
 |
| Micro-X CNT source ( from https://www.aumanufacturing.com.au/micro-xs-carbon-nanotube-x-ray-machine-in-clinical-use ) |
And where is that Nanox source that can be embedded inside a medical imaging system and operate with an acceptable lifespan? Or did he mean a cheap underpowered hot-cathode Chinese source not suitable for medical imaging?
Note: High current with a maximum emitter current of 130mA for up to 2 seconds per tech page. Compare to Nanox 11mA "proposed" hand-made "hight [sic]" chart.
January 04, 2021
A cautionary tale
The Dominion Volumetric Imaging Scanner by Imaging3 was supposed to be the first ever system that could produce a combination of 2D, 3D, and CT imagery in a single device, including live stream (fluorosocopy) - high quality 2D images in Continuous 2D Scan mode, high quality 3D images in Continuous 3D Scan mode, and Single 3D SafeScan mode. The unique engineering design accomplished these capabilities while dramatically reducing exposure to radiation, and providing a small, mobile footprint for easy transport, all at a cost of about one third of existing CT devices.
Sounds and looks familiar?
It was all a scam.
Here is the FDA rejection letter. Some more details here, and the SEC complaint.
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| image source: www.imaging3.com |
Thanks to Fleipeg on Seeking Alpha for bringing it to my attention.
Puzzles
This was Nanox.Arc version 1.5, per tech page.
 |
| source: front-page video titled "Understanding Nanox technology & vision" (vimeo ID 393211389) |
Note: Slight change in the design of the Arc in the video - is that Arc 1.4 or 1.6?
January 02, 2021
Reference list
Photon-counting CT:
Photon-counting CT: Technical Principles and Clinical Prospects, 2018, Pelc etc
Photon-counting Detector CT: System Design and Clinical Applications of an Emerging Technology, 2019 (EID is the conventional energy integrating detector)
Cold cathode:
Advances in cold cathode physics and technology, 1999 old, Israeli
Fuji S-value:
Investigation into Factors Influencing Fuji S-Value Using an Extremity Phantom, 2011
HVL:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/performance-standard-diagnostic-x-ray-systems-and-their-major-components-21cfr-102030-102031-102032 (21 CFR 1020.30(m), Table 1, over 1.3mm above 51kVp)
IEC 60601-1-3, Table 3 , HVL is 2.0mm for 55kV ( per 2013 edition) / IEC 60601-1-3 is referenced by IEC 60601-2-54 which is in FDA's Recognized Consensus Standards for mobile x-ray systems.
Benefits of Tomo:
Digital Tomosynthesis to Evaluate Fracture Healing: Prospective Comparison With Radiography and CT, 2015
Tomosynthesis:
https://github.com/LAVI-USP/DBT-Reconstruction
accompanying paper with 9 projections, 1mm or 0.1mm detector pixel, compares to Senographe Essential (PMA)
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2832060/
a 2009 paper that was still hopeful about tomosynthesis.
Intro for technologists (Hologic, Siemens, projections, seconds, algorithms, slabs, screening?)
Tube current exposure time product (mAs):
https://www.upstate.edu/radiology/education/rsna/radiography/mas.php
CNT XinRay, etc:
https://www.aapm.org/meetings/amos2/pdf/42-11909-37935-43.pdf , 2009, when things looked promising.
Field Emission Displays
The unpublished history of FED, up to Sony.
Predecessor datasheets
FDA:
https://www.mobihealthnews.com/news/commentary-digital-health-companies-should-stay-away-fda-2021 some interesting points re current state of De Novo affairs
FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals , 2017 (tells what happens if the submitter simply does not respond fully to a request that would self-incriminate it - deletion/withdrawal).
COVID-related impact Q&A December 2020, and other guidance.
Third Party guidance March 2020 - steps/clocks/terminology such as "early interaction," "review memorandum," "review documentation," "cover letter, " "role of a consultant," "rerecognition."
The 3P510k Review Organization should send to FDA via e-mail to 3P510K@fda.hhs.gov information on any complaint (e.g., whistleblowing) it receives about a 510(k) Submitter that could indicate an issue related to the safety or effectiveness of a medical device or a public health risk.
Section 523(b)(3)(F)(iv) requires 3P510k Review Organizations to agree that they will promptly respond and attempt to resolve complaints regarding its activities for which it is accredited. FDA recommends that 3P510k Review Organizations establish a recordkeeping system for tracking the submission of those complaints and how those complaints were resolved, or attempted to be resolved.
Guidance if the 510k submitter chooses to utilize standards.
An order declaring a device to be NSE (NSE letter) is a letter issued to a 510(k) submitter stating that FDA has determined that the device described in the 510(k) submission is not substantially equivalent to any legally marketed device and may not be introduced into commercial distribution in the U.S
the device has a new intended use compared to the identified predicate device;
Found this submission guide useful (e.g., summary gets published within 30 days)
510(k): substantial equivalence , format, content, foreign tests, clinical data.
CE Marking:
The Medical Devices Regulation - Where Are We Now?: The new MDR now requires total life cycle traceability between all stages of product development and post-market activities. General safety and performance requirements (GSPR) checklists have been mandated. Clinical evidence is now required for all medical devices. // The MDCG on Clinical Investigation and Evaluation released four guidance documents on 23 April 2020 to assist with some of the key clinical requirements outlined in the Medical Device Regulation (MDR). The documents include Guidance on Clinical Evaluation – Equivalence, Guidance on Sufficient Clinical Evidence for Legacy Devices, PMCF Evaluation Report and Guidance on PMCF Plan Template.
Updated: October 7, 2021
January 01, 2021
The mystery CT machine
What was the mystery device behind Nanox CEO back during the RSNA 2020 demo?
I think it is a Canon/Toshiba Aquilion CT model, with a tilting gantry. But the current AuntMinnie consensus is that it looks like an inflatable mockup, just like the company itself.
Full-body scan vision
According to Nanox CEO,
"Nanox.Arc could provide a full-body digital X-ray scan ... Most, if not all, cancers can be treated rather easily if found early enough through medical imaging. The World Health Organization says if every person had a full-body scan once a year, potentially millions could be saved by early detection." (Israel21c, March 23, 2020)
The problem is that the World Health Organization never said that. In fact, it said exactly the opposite:
Whole body CT for IHA [individual health assessment] of asymptomatic individuals should cease.
Nanox vision is based on a lie.
Nanox has backtracked since - now it is early detection of SYMPTOMATIC PATIENTS only!
Here is what the American Academy of Family Physicians says:
"Whole-body scanning is not recommended by medical professional societies for individuals without symptoms, nor is it a routinely practiced screening procedure in healthy populations."
Choosing Wisely, an initiative of the American Board of Internal Medicine, in cooperation with Consumer Reports and American and American College of Preventive Medicine has this to say about whole-body scans:
"They don’t help find cancer—and may do more harm than good... No medical societies recommend whole-body scans. That’s because there is no evidence that the scans are a good screening tool. Whole-body scans can lead to unnecessary follow-up tests."
Further reading:
Radiation Risk From CT: Implications for Cancer Screening, Jeffrey M. Albert
The available data suggest a small but real risk of radiation-induced malignancy from CT that could become significant at the population level with widespread use of CT-based screening. However, a growing body of literature suggests that the benefits of CT screening for lung cancer in high-risk patients and CT colonography for colorectal cancer may significantly outweigh the radiation risk. Future studies evaluating the benefits of CT screening should continue to consider potential radiation risks.
See also CT Radiation Dose and Risk: Fact vs Fiction
technologists also must consider the risks of reducing dose to the point that image quality falters or diagnoses are delayed or missed.
Average doses.
Pro mammo screening.
On mammograms and AI, rather than full-body, but article wrong about tomo for screening (note: Nanox.Arc can't do mammograms, compare to no squish, January 29, 2021):
More-aggressive screening strategies aim to maximize the benefits of early detection, whereas less-frequent screenings aim to reduce false positives, anxiety, and costs for those who will never even develop breast cancer.
“We know MRI can catch cancers earlier than mammography, and that earlier detection improves patient outcomes,” says Yala. “But for patients at low risk of cancer, the risk of false-positives can outweigh the benefits. With improved risk models, we can design more nuanced risk-screening guidelines that offer more sensitive screening, like MRI, to patients who will develop cancer, to get better outcomes while reducing unnecessary screening and over-treatment for the rest.”
December 29, 2020
The testimony at RSNA 2020 that disappeared
This testimony was removed after briefly appearing in a longer video on Nanox' RSNA 2020 virtual booth on November 29, 2020 (days ahead of the live presentation).
Per Nanox prospectus:
In addition, we signed an agreement with a President of SK Telecom, Dr. Ilung Kim, dated December 16, 2019, for the provision of consulting services to us. Under the agreement, we granted Dr. Kim options to purchase 1,206,290 of our ordinary shares at an exercise price of $2.21 per ordinary share. 301,572 of the options vested as of the grant date and the remaining 904,718 options will vest in equal monthly installments over a period of three years from the vesting commencement date. In case of an initial public offering or certain other events, all unvested options will fully accelerate immediately prior to the closing of the initial public offering. The vested options are exercisable until the earlier of (a) the second anniversary of termination of the engagement between us and Dr. Kim or (b) the tenth anniversary from the date of grant.
So why did it disappear? High-cost of tubes, not ready for mass production, anything else?
Update March 30,2021:
Well, turns out Dr. Kim was a marketing SVP and GM of Samsung Memory from 1999 to 2008, according to a recent press release announcing his joining MCE's advisory board. Turns out, a Dr. Kim, vice president of marketing for the memory division at Samsung, agreed to plead guilty to a single count of price fixing in 2007. Dr. Kim was later sentenced to pay a fine of $250,000 and to "a period of incarceration of fourteen months." And who claims to be working as a Marketing Managers for MCE? Eli Reifman, the convicted felon. Both Lydia Edwards, who is President, USA at Nanox, and Bruce Edwards, who is Nanox’s VP of Business Development used to work with Mr. Reifman.
And one more thing: He was on the list of Nanox representatives at the November 2020 Berenberg "CEO" conference.
Thanks to Steve @ Yahoo and MuddyWaters' report for the hints.
Update March 31, 2021: The draft registration statement filed on January 14, 2021 had the date of Dr. Kim agreement as October 28, 2019. Apparently, Nanox had forgotten that the agreement with Dr. Kim had been modified on December 16, 2019 to allow for full vesting of the options prior to the IPO...
Update August 1, 2021: Dr. Kim, a convicted felon who swindled SK Telecom into investing in Nanox and therefore received the most generous consulting fee from Nanox, has "left" SK Telecom two months ago, and joined Nano-X Korea Ltd. full-time in July ("Responsible for Korean Fab Operation, X ray Tube R & D and AP area sales and marketing", per his linkedin profile). I first learned it from a June 30 MCE "article", which refers to him as a "former President SK Telecom." The promotional piece appears authored by Eli Reifman, a convicted felon who claims to be Marketing Manager at MCE. Reifman may still have an email address at Nanox (according to an email verification service), and may be affiliated with A-Labs (A-Labs supposedly denies it), which provided "consulting services" in connection "with various transactions, such as a private placement [and] ... initial public offering." For example, A-Labs touted nine months ago the Monolith, the "world's first full-screen smartphone designed by Eli Reifman, founder of Emblaze Ltd. in 2001 with R&D initiated in 2004 which is 3 years before Apple's steve jobs introduced the first iPhone in 2007."
Here is an August 2020 Israeli article explaining (google translate):
The Emblaze consulting firm cuts millions of dollars in coupons in Nanox and INX offerings
Eli Reifman is not officially affiliated with A-Labs, one of the biggest beneficiaries in the Nanox IPO • The company is owned by Doron Cohen, former vice president of technology company Emblaze, along with Roni Lieberman, who briefly served as VP of product at Emblaze
Gali Weinreb 23.08.2020
Eli Reifman. Affair that began with his conviction in 2011 / Photo: Tamar Mitzpi, Globes
A-Labs, which served as a consultant for the Nanox IPO , is one of the biggest beneficiaries of the move. As recently revealed in "Globes", this is a company founded by the graduates of the technology company Emblaze by Eli Reifman , and according to market estimates, Reifman is significantly involved in it. A-Labs itself admittedly denied that Reifman was officially associated with her, but the company's CEO and founder, Doron Cohen, noted that Reifman is a friend and sometimes advises him in a friendly manner.
Under the consulting agreement between the companies, A-Labs received a 2.5% success fee from the issue amount - approximately $ 4 million, an additional payment of $ 1 million due to the issue itself, and another 160,457 options at an exercise price of $ 16 (compared to $ 18 per issue), equivalent to At the time of the IPO, another $ 300,000. A-Labs advises in a similar format to other Israeli companies, and it was recently announced that it is expected to pocket millions of additional dollars from the issuance of the crypto company INX in the USA ( see separate article ).
Reifman is not officially affiliated with A-Labs. The company is owned by Doron Cohen, formerly vice president of the technology company Emblaze, together with Roni Lieberman, who briefly served as VP of product at Emblaze. Its vice president of operations, Raviv Pablo, also previously worked at Emblaze.
Clues to the fact that Reifman is involved in the company can be found, for example, in the fact that Scratch Alter, who was defined in the court document as "Reifman's relative" in the matter of providing a guarantee for him, is the head of the life sciences department in the company. In addition, the company's offices are located in Kadima, where Reifman also lives.
Recent issues involving A-Labs have included issues of Israeli companies in Canada: Zoomd, which provides website search engine technology, and Else, which has developed a vegan baby food compound.
Eli Reifman is the founder of the technology company Emblaze, which has developed technology in the field of digital video. In the past, Reifman was considered a "child prodigy" in Israeli high-tech, however, he became involved in crime and accumulated debts in the gray market.
In 2011, Reifman was convicted of forgery and fraud and sentenced to four years in prison and compensation to the complainants against him. Following an appeal he filed, the Supreme Court dismissed his appeal and he went to jail, from which he was finally released a year and a half before the end of his full sentence.
Reifman founded Emblaze in 1994. The company was issued in London in 1996, and its value rose from $ 160 million at the time of the IPO to about $ 8 billion at its peak. Reifman sold tens of millions of dollars worth of shares in the company, and became one of the most prominent high-tech rich in the economy before the dot.com bubble burst.
Facts and Distortion
"Personally I never care for fiction or story-books. What I like to read about are facts and statistics of any kind. If they are only facts about the raising of radishes, they interest me. Just now, for instance, before you came in"—he pointed to an encyclopedia on the shelves—"I was reading an article about 'Mathematics.' Perfectly pure mathematics.
"My own knowledge of mathematics stops at 'twelve times twelve,' but I enjoyed that article immensely. I didn't understand a word of it: but facts, or what a man believes to be facts, are always delightful. That mathematical fellow believed in his facts. So do I. Get your facts first, and"—the voice dies away to an almost inaudible drone—"then you can distort 'em as much as you please." (Mark Twain, according to Rudyard Kipling)
First digital source
In its "first" press release issued in November 2019, Nanox says:
Nanox, founded by the serial entrepreneur Ran Poliakine, is an Israeli/Japanese cooperation that has created the world’s first commercial-grade digital X-ray source for real-world medical imaging applications
How do you define digital? Roentgen used a cold-cathode (gas discharge) tube when he discovered X-rays, and so did all commercial X-ray sources until 1913. Carestream/Micro-X/XinRay got clearance for the mobile x-ray unit that uses CNT tubes in February 2018.
 |
| Crookes tube, source: https://www.emory.edu/X-RAYS/century_02.htm |
Update March 31, 2021: Vatech got clearance for its dental x-ray system that uses a CNT tube (V1-650304) in September 2016.
December 28, 2020
Why Nanox source is digital
Because it is digitally switched with low voltage (30V+), according to this patent. But so is any hot-cathode source, with filament voltage as low as 3V, and possibly an extra grid or Wehnelt cup electrode.
 |
| Wehnelt cup (source: Lambtron at Wikipedia) |
Update March 24, 2021: A good slide from a IAEA on grid-controlled tubes use in pulsed fluoroscopy:
How fast can you switch? A 1984 paper says pulse width down to 19 microseconds (says that at the time, fluoroscopy and CT did not requires pulse widths less than 1 millisecond). The 120kVp is switched with 3.7kVp at the grid, tube current is 125mA
Update April 6, 2021: The switching grid, or focusing cup, is negatively biased toward the cathode (filament), at about 1kV (while in a conventional tube, the cup is connected to the filament)
December 26, 2020
Nanox uncertainty principle
Per Nanox tech page, the temperature of a (filament in a) hot cathode can never be measured, because
Hot cathode temperature is over 2000 degrees Celsius
, but it is
operating at temperatures of up to 2000°C.
 |
| Hot cathode (source: Nanox website, "Understanding Nanox technology & vision" video) |
December 25, 2020
WHIS-RAD, WHO's alternative to Nanox Vision
Nanox Vision is a cancer-inducing initiative contradicting the ALARA principle and ImageWisely, as proclaimed in the joint June 2019 press release with SK Telecom:
nanox.vision is the global initiative led by nanox and world-leading healthcare players to drive the 1x1x1 vision of at least one medical screening for each person on the planet each year. The 1x1x1 Initiative is based on nanox's revolutionary MEMs X-ray source and encompassing ecosystem of partners to provide affordable, early detection for all.
Note that early detection has actually two separate components: 1) early diagnosis and 2) screening.
Nanox falsely claims in its prospectus:
We believe [heat and complexity] key factors leading[sic] to the high cost and complexity of existing medical imaging systems, which in turn significantly limits the availability of medical imaging for early detection globally. According to a report from the Pan-American Health Organization and the World Health Organization (“WHO”) in 2012, approximately two-thirds of the world population did not have access to medical imaging, while many people with access to medical imaging face substantial wait times for scanning.
What the WHO report actually says is:
The use of X-rays and other physical waves such as ultrasound can resolve between 70% and 80% of diagnostic problems, but nearly two-thirds of the world's population has no access to diagnostic imaging [not the same as medical imaging, see above]
Nanox fails to mention WHIS-RAD, WHO's proposed solution. WHIS-RAD system was developed by the WHO in collaboration with radiographer experts. It was designed to provide high-quality images and to be safe to use, reliable, easy and simple to learn. Additionally, it is designed to operate where power is unreliable or unavailable for extended periods of time. So much for Nanox Vision!
 |
| WHIS-RAD (source: Red Cross, see link below) |
"Providing low-cost, high-quality x-ray units was the goal behind development of the WHO's basic radiology system" (Alternatives to WHIS-RAD units fall short.)
WHO's purchasing guide states that the first imaging unit any hospital should buy is a general-radiography x-ray system like WHIS-RAD, which automatically eliminates both single-source and multiple-source Nanox.Arc, due to their low power and inability to do standard chest x-ray. So much for Nanox conquering the world!
Recent assessment notes that the equipment works well and easily satisfies the requirements of the original design, and is adapted to the digital age, but notes some reasons for the low number of installations. Cost is about $45,000-$50,000 (Radiology for the People: A Basic Radiological System for Health Care inDeveloping Nations, 2019)
Resources:
WHIS-RAD technical specifications.
Copy of presentation slides covering WHIS-RAD (original link no longer available).
WHIS-RAD tech background (Chapter 10 from The WHO manual of diagnostic imaging. Radiographic technique and projections by Staffan Sandström)
Rotary WHIS-RAD project.
Red cross example ($46,000 is an undated "budget" cost)
Benefits of U-arm and straight arm systems.
Useful WHO docs:
2016 RAD-AID Conference overview.
Update March 26, 2021: Arsakaan @ Twitter reminded me again why Nanox should not be allowed to market/promote ANY medical device. Nanox is not just some investment fraud - with its incompetence, it endangers lives, even if it has no intention to ever shipping any working device. The snapshot from the current Nanox webpage still shows this overlay:
Update May 20, 2021: added a link to screening definition from the U.S. Department of Health and Human Services.
December 24, 2020
The other Nanox
The stationary CT by NanoVision, not to be confused with Nanox.Vision, demoed (illegally, I think) at RSNA2019. Claims:
"FDA 510(k) in the process of applying."
The device actually appears feasible, but it does not make sense, as the image quality will not match that of regular CT while the manufacturing cost will be higher due to the performance demand on the detectors.
Update November 17, 2021: NanoVision will be presenting the same video and same disclaimer "FDA 510(k) in the process of applying" virtually at RSNA 2021. Sure.
December 23, 2020
No comment
From the Korean press in September 2020:
 |
| Nanox CEO presenting (source: Pulse, Sept 9, 2020, by By Kim Ki-cheol, et al.) |
Existing X-ray and CT machines cost over billions of dollars to set up, with one-time imaging over $100. Nanox device costs about $10,000 with one-time imaging about $1.
Here is a comment anyway: Anything is possible in Korea.
December 20, 2020
Hypothetical predicate
Hypothetically, if someone were to submit for 510(k) clearance a single-source device like the one demoed by Nanox at RSNA2020, what would be the proper predicate (ignoring the DR detector)?
There are 71 product codes for x-ray, of which only two appear relevant:
1. IZL is "mobile" (which includes portables, some even using dental tubes, and devices on wheels, list, annotations, 3rd party: 8):
"A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories."
2. KPR is "stationary." (list, 3rd party: 18):
"A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories."
Note: Code MWP is not appropriate, since it is an enclosed "cabinet" system not for imaging humans directly, but has a redacted 510(k) submission by Hologic which may be potentially useful)
An interesting clearance under JAK product code (uses K160857 as KPR reference, just for hands and feet: old manual).
WHO apparently required (requires?) 11kW tube for stationary (so Nanox is out, I believe) and says mobile is not essential in many small hospitals but may be needed for orthopedic surgery.
Screenshots from Nanox RSNA2020 demo (vimeo 487071020/487132636) showing views of the single-source device "pending clearance:"
Other notes: Two portables, Micro C (fluoro) and Fuji's Xair are waiting for years for 510(k) clearance and haven't gotten it yet. The operator will probably need lead apron. Fuji is supposedly doing trials in 2020. Micro C/Oxos looks like a scam (based on the hype in some local press articles and in a NASA presentation ; claims testing at Intertek for IEC 60601-1). Note: Jan 18/Feb13, 2021: Wow, Micro-C got cleared (summary, through a 3rd party within 30 days, initially expected December 2018, but turns out submitted again November 16, 2019, and delayed). Note Mar 30, 2021: But Micro-C was initially promoted as a fluoroscopic device (product code JAA), instead it got cleared as a portable x-ray device only (product code IZL) for extremities (static and "serial")
Further notes added on Jan 5, 2021: A review of possible x-ray systems (including tomo, fluoro, C-arm, CT, etc) shows only 10 clearances in the past 5 years that involved a Third Party Review, by only two Organizations that are still active in the Program. Here is the list: K203216, K203187, K202564, K201053, K180727, K170789, K170716, K170221, K161920, K160315. Time from recommendation to clearance ranged from 2 to 52 days. Nanox is in trouble (if it ever submitted anything for clearance, of course).
Note (Jan 15, 2021): A potential predicate for the multi-source device (video), but not a good one, as the Shimadzu unit has a powerful x-ray tube (added Mar 11, 2011).
Update June 22, 2021: The predicate (which Nanox could not get right in its 510K Summary) is described in this blog post.
December 18, 2020
Nanox.Arc assembly quality?
This looks like shoddy assembly quality and cheap disintegrating plastic. Or is the camera lying? From video titled "The making of Nanox ARC" (about 1:06 into video).
Nanox.Arc is not production-ready
The multiple-source Nanox.Arc "prototype" shown at RSNA2020 supposedly represents what Nanox is "going to make," with the design being 100% finalized (per investor Zoom event following the RSNA 2020 demo, about 55 minutes into it). However, the device lacks a built-in high-voltage generator necessary to produce any x-rays.
The CEO says (about 53 minutes into the Zoom) when asked about the location of he high-voltage receptacl: "inside the gantry we have connecting [sic] one by one the tubes into the high-power voltage and all the way to a PCB card that is then connecting to the high-power supply."
This snapshot from Nanox video titled "The making of Nanox ARC" (about 1:03 into video) shows the black high-voltage cable leading away from the device to a generator that is not visible (and may not even exist).
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