!M1

The !M1 is a mobile X-ray system designed to perform general radiography examinations on pediatric and adult patients in professional healthcare facilities. It uses digital radiography (DR) technology with a self-contained X-ray generator, flat-panel detector(s), imaging display, and software to acquire diagnostic images both inside and outside standard stationary X-ray rooms.

The subject device adds optional performance enhancements to the predicate: an automatic motorized collimator (versus manual), increased maximum kV from 125 to 133 kV, increased maximum mAs from 320 to 400 mAs, and increased maximum power from 32 to 40 kW. It also integrates new detector options from Canon Medical Systems, Konica Minolta, and Vieworks with improved pixel sizes, MTF, and DQE values compared to prior generations.

Compliance cited with EN ISO 13485:2016 (quality management), EN ISO 14971:2020 (risk management), EN 60601-1:2021 (medical electrical equipment safety), EN 60601-1-2:2015 (EMC), EN 60601-1-3:2008 (radiation protection), EN 60601-2-28:2010 (X-ray tube assemblies), EN 60601-2-54:2009 (X-ray radiography equipment), EN 62304:2015 (software lifecycle), and EN 62366-1:2015 (usability engineering).

The subject device maintains identical intended use, technology platform, and most components as the predicate (K170607). Performance enhancements to the generator, X-ray tube, and collimator only improve device capability with no negative impact on safety or effectiveness. Integration of additional detector and software options from established manufacturers provides wider configuration choices but does not alter the fundamental scientific technology or operational principle of the mobile X-ray system.