TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)

The TOPAZ Mobile X-ray System is a mobile radiography device intended for obtaining human anatomical images of patients who cannot be moved to a radiology department for medical diagnosis. It consists of an X-ray tube assembly, collimator, high-voltage generator, flat-panel detector, and mechanical components for mobility, with a touch-screen control console for technique selection.

Key changes from the predicate device include software update from TPZ_IWS to RADMAX with improved graphical user interface and added image processing modules (Module 3 and 4); a new collapsible column stand option in addition to the basic type; a 21.5-inch capacitive touch monitor; and addition of seven new FDA-cleared wireless flat-panel detectors (Luna1012X, Mars1417X, Mars1717X, 4343W, A1417MCW, A1717MCW, F1417MCW). The collapsible column adds 330-degree rotation capability versus the basic column's 325-degree range.

IEC 60601-1, IEC 60601-1-2 (EMC), IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-28, IEC 60601-2-54, IEC 62304, ISO 14971, ISO 15223-1, NEMA PS 3.1-3.20 (DICOM), IEC 62494-1, and 21 CFR 1020.30-31. All testing was performed by accredited Safety and EMC testing laboratories.

The subject device is substantially equivalent because it maintains identical system control, indication for use, and mechanical design principles as the predicate TOPAZ Mobile DR System (K201124). All differences—software enhancements, new detectors, monitor upgrade, and collapsible column option—have been verified through validation testing to meet predetermined acceptance criteria and International Safety/EMC standards with no negative impact on safety or effectiveness. The added detectors are all separately FDA-cleared, and verification testing confirmed no adverse impacts on device safety or performance compared to the predicate system.