510(k) K926251

B-SCAN OPTHALMIC ULTRASOUND IMAGING SYSTEM by Biovision, Inc. — Product Code IYO

K926251 is an FDA 510(k) premarket notification submitted by Biovision, Inc. for the device "B-SCAN OPTHALMIC ULTRASOUND IMAGING SYSTEM". The FDA issued a decision of Substantially Equivalent on September 14, 1993. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Biovision, Inc. has at least 5 other 510(k) clearances on record.