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510(k) Data Aggregation
(147 days)
The AirRay-mini is a handheld, portable X-ray generator.
This device is intended for use by qualified and trained healthcare professionals on adult patients to produce diagnostic X-ray images of the extremities.
This device is not intended for mammography.
The AirRay-mini is a portable, battery-powered X-ray generator intended to provide controlled X-ray radiation for use with separately cleared solid-state detectors or digital radiography systems. The device consists of an X-ray control unit, a high-voltage generator, an X-ray tube assembly, a hand switch, and associated electronics.
DC power from the internal battery is supplied to the inverter, which generates a high-voltage output applied across the X-ray tube. Electrons emitted from the cathode are accelerated toward the anode target, where their deceleration produces X-ray radiation. The device delivers X-rays according to user-selected parameters such as tube voltage (kV), tube current (mA), and exposure time (mAs).
The AirRay-mini does not include an image receptor and does not acquire or process diagnostic images. Diagnostic image formation and quality depend entirely on the separately paired imaging system.
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