A coal miner under the Arc

Not possible, says the United States Code of Federal Regulations.  Coal mine operators are required to provide radiographic examinations to each coal miner, and, for some reasons, the law insists on certain minimum specs of the equipment.  Nanox.Arc cannot meet them.

Original credit:  Jean Beaufort

Here are some of the specs for a digital radiograph (42 CFR 37.42) that Nanox.Arc fails:

Every digital chest radiograph taken as required under this section must be a single posteroanterior [PA] projection

Nanox.Arc cannot take PA projections (it can only do supine AP).

Radiographs must be made with units having generators which have a minimum rating of 300 mA at 125 kVp. Exposure kilovoltage must be at least the minimum as recommended by the manufacturer for chest radiography.

Nanox tube is rated just 2mA at 40 kVp, per 510K Summary for Nanox.Cart.  Nanox partner CEI has been supposedly trying hard for months to make 1mA at 100 kVp, but has failed so far.

The distance from source or focal spot to detector must be at least 70 inches (or 180 centimeters if measured in centimeters);

The Arc is too tight and the distance is less than 40 inches.

The geometry of the radiographic system must ensure that the central axis (ray) of the primary beam is perpendicular to the plane of the CR imaging plate, or DR detector and is correctly aligned to the grid;

The requirement above is met by only one of the 5 tubes in the Nanox.Arc, in only one, the no-tilt, position of the Arc.

Now, if the Arc cannot even do a simple radiograph worthy of a coal miner,  why does Nanox still tell investors that the Arc can be used for chest diagnostics?

Slide from Cantor investor presentation (September 29)

Moreover, does the FDA clearance submission of the Nanox.Arc list chest diagnostics as an indication/intended use?  That would be a bit fraudulent, no?