
Afp Imaging Corp.
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MODIFICATION TO: SENS-A-RAY SYSTEM WITH PROIMAGE SOFTWARE is an FDA 510(k)-cleared medical device (K013176) manufactured by Afp Imaging Corp.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 15, 2001. Regulation: 8.