REMEX Xcam6

The REMEX Xcam6 is a handheld, portable X-ray system designed to produce diagnostic radiographic images of patient extremities in hospital or clinic settings. It functions as an X-ray source used with an external flat panel detector and computer with imaging software, and can operate in handheld or stand-mounted configurations. The device is not intended for mammography or to replace stationary radiographic systems.

The REMEX Xcam6 is significantly more compact and lightweight (2.4 kg vs. 7.7 kg) than the predicate TR90BH, uses a different X-ray tube (Canon D-041SB vs. D-0814M) with smaller focal spot (0.4 mm vs. 0.8 mm), and features different power specifications. Both devices offer similar tube voltage ranges (40-90 kVp), but the subject device has lower tube current (2-6 mA vs. up to 20 mA) and different exposure time capabilities. Total filtration is similar (3.6 mm Al vs. minimum 3.0 mm Al), and both use identical source-to-skin distance and radiation field geometry.

Testing followed IEC 60601 series standards (parts 1, 1-2, 1-3, 1-6, 2-28, 2-54), ISO 14971 risk management, IEC 62304 software lifecycle, IEC 62366-1 usability engineering, ISO 15223-1 medical device symbols, and 21 CFR 1020.30 and 1020.31 for diagnostic X-ray systems. Electrical safety, EMC, image quality, dosimetry, software verification/validation, and limited clinical testing were all performed.

Both devices share identical regulatory classification (21 CFR 892.1720, product code IZL), intended purpose (portable X-ray imaging of extremities), and fundamental operating principles. Although the REMEX Xcam6 is narrower in clinical scope (extremities only vs. head, abdomen, chest, and extremities), this represents a subset use rather than a material alteration to primary intended use. Design differences in size, weight, and X-ray tube configuration reflect portability enhancements rather than safety or effectiveness changes. Bench testing confirmed equivalent image quality and dosimetry characteristics, and clinical testing verified diagnostic capability. The lower tube current and different exposure parameters have been validated and do not introduce new safety concerns.