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The unpublished history of FED, up to Sony.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
