510(k) K013176

MODIFICATION TO: SENS-A-RAY SYSTEM WITH PROIMAGE SOFTWARE by Afp Imaging Corp. — Product Code EHD

K013176 is an FDA 510(k) premarket notification submitted by Afp Imaging Corp. for the device "MODIFICATION TO: SENS-A-RAY SYSTEM WITH PROIMAGE SOFTWARE". The FDA issued a decision of Substantially Equivalent on October 16, 2001. The device falls under product code EHD (Unit, X-Ray, Extraoral With Timer), a Class II device regulated under 21 CFR 872.1800. Afp Imaging Corp. has at least 10 other 510(k) clearances on record.