PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS

The PRORAD ATLAS ULTRAPORTABLE and ULTRAPORTABLE PLUS are battery-powered portable X-ray systems designed to produce diagnostic radiographic images of body extremities in pediatric and adult patients. They are intended for use in healthcare centers, emergency departments, mobile clinics, and remote telemedicine settings, operated by trained radiographers, technologists, and medical professionals.

The subject devices are fixed 70 kVp systems with 2 mA (ULTRAPORTABLE) or 6 mA (PLUS) tube current, differ in exposure time ranges (0.01–1.30 sec vs. 0.01–2.5 sec), use different X-ray tubes and focal spot sizes, incorporate tripod mounting, lithium-ion battery power for 100 exposures per charge, and integrate with multiple FDA-cleared flat-panel detectors via wireless transmission. They differ from the predicate in battery voltage, size, weight, collimator design, and software but maintain identical intended use, anatomical site, and user qualifications.

IEC 60601-1:2005 (with amendments), IEC 60601-1-2:2014, IEC 60601-2-54:2022, IEC 60601-1-3:2021, IEC 62366-1:2015, IEC 62304:2015, ISO 14971:2019, ISO 15223-1:2021, ISO 20417:2021, ISO 10993-1:2018, and FDA guidance on medical device cybersecurity and software.

The subject device shares identical regulatory classification (Class II, 21 CFR 892.1720), product code, and intended use (diagnostic imaging of body extremities) with the predicate Remex KA6. Although technical differences exist in battery capacity, tube specifications, and user interface, these are minor design variations that do not change the fundamental function or raise new safety concerns. Both use rechargeable batteries, dual-stage triggering, digital radiography detectors, and are operated by trained personnel. Verification, validation, and clinical testing (radiologist review of collected extremity images) demonstrate the subject device performs safely and effectively as intended.