510(k) K893996

CUSIS ULTRASOUND SKIN IMAGING SYSTEM by Stiefel Research Institute, Inc. — Product Code IYO

K893996 is an FDA 510(k) premarket notification submitted by Stiefel Research Institute, Inc. for the device "CUSIS ULTRASOUND SKIN IMAGING SYSTEM". The FDA issued a decision of Substantially Equivalent on September 21, 1989. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Stiefel Research Institute, Inc. has at least 5 other 510(k) clearances on record.