INNOVISION-P5

The INNOVISION-P5 is a portable battery-operated X-ray system designed for diagnostic imaging of body extremities. It consists of an X-ray generator, tube assembly, collimator, flat-panel detector, and imaging software, and can be used handheld or with an optional stand. The device is not intended for mammography or to replace stationary radiographic systems.

Key differences from the predicate device include smaller size and weight (3.5 kg vs. 7.5 kg), different battery chemistry (Li-Polymer 29.6V vs. Lithium-ion 57.6V), lower maximum output power (720W vs. 1.35kW), smaller focal spot (0.5mm vs. 0.8mm), different X-ray tube model, and different flat-panel detector and imaging software. Similarities include kV range (50-90 kVp), manual collimator adjustment, and same general functional capabilities.

IEC 60601-1 (general safety), IEC 60601-1-2 (electromagnetic compatibility), IEC 60601-1-3 (radiation protection), IEC 60601-2-28 (X-ray source assembly safety), IEC 60601-2-54 (X-ray equipment for radiography), IEC 62304 (software lifecycle), IEC 62133-2 (lithium battery safety), IEC 81001-5-1 (health IT security), AAMI TIR57:2016 (medical device security), NEMA PS 3.1-3.20 (DICOM), and FDA guidance on cybersecurity and software.

The subject device has the same indications for use (diagnostic imaging of body extremities) and similar performance characteristics as the predicate. Although multiple components differ in specifications (size, weight, power output, focal spot, detector, software), each difference was tested and verified to not raise new safety or effectiveness concerns per FDA-recognized standards. Clinical image evaluation confirmed the device meets diagnostic radiography standards with high-resolution output comparable to the legally marketed predicate device.