DRGEM Corporation · Class II · Cleared Jan 7, 2025
| K-number | K242019 |
| Device name | GXR-Series Diagnostic X-Ray System |
| Applicant | DRGEM Corporation |
| Product code | KPR |
| Device class | Class II |
| Decision date | Jan 7, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 892.1680 |
The GXR-Series Diagnostic X-Ray System is a stationary x-ray imaging device intended for obtaining human anatomical images for medical diagnostic purposes. It consists of a high-frequency x-ray generator, tube stand, patient table, wall Bucky stand, and either analog or digital imaging components (flat panel detectors for digital models). The system operates at 40–125 (150) kVp and 10–400 (500) mA to generate radiographic images for diagnostic interpretation by physicians.
The subject device adds new flat panel detector models (Luna1012X, Mars1417X, Mars1717X, and H&abyz models), new patient table options (PBT-6 Deluxe), new wall Bucky stands (WBS variants with motorized and actuator options), new tube stand variants (TS-CSP with 15-inch LCD), and new tube housing assemblies (RTM90HS, RTM101HS, RTC600HS, UH-6FC-31E). The imaging software RADMAX was updated with an improved graphical user interface and a new image processing module (Module 4). OEM variant models (FDR Clinica FGXR series) are included, differing only in labeling, color, and model name from the base GXR models.
Testing followed IEC 60601-1-3 (radiation protection), IEC 60601-1-6 (usability), IEC 60601-2-28 (x-ray source safety), IEC 60601-2-54 (radiography/radioscopy safety), IEC 60601-1-2 (EMC), IEC 62304 (software lifecycle), IEC 62366-1 (usability engineering), ISO 14971 (risk management), ISO 15223-1 (labeling symbols), NEMA PS 3.1-3.20 (DICOM), and IEC 62494-1 (exposure index). Compliance with 21 CFR 1020.30 was verified.
The subject device shares the same intended use, intended patient population, and fundamental operating principles as the predicate (K202572). All new components (flat panel detectors, tables, stands, tube housings) are from FDA-cleared suppliers or DRGEM manufacturing to established specifications. The software updates (GUI improvements and Module 4 image processing) underwent verification and validation testing with no impact on safety or effectiveness. OEM variant models are cosmetic variants with identical specifications. All differences underwent testing against International Safety and EMC Standards with predetermined acceptance criteria met, establishing no new potential or increased safety risks.
View the full FDA submission: accessdata.fda.gov