510(k) K991842

SYSTEM FIVE/ECHOPAC WITH STRAIN RATE IMAGING by Ge Vingmed Ultrasound — Product Code IYO

K991842 is an FDA 510(k) premarket notification submitted by Ge Vingmed Ultrasound for the device "SYSTEM FIVE/ECHOPAC WITH STRAIN RATE IMAGING". The FDA issued a decision of Substantially Equivalent on June 11, 1999. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Ge Vingmed Ultrasound has at least 10 other 510(k) clearances on record.