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.