510(k) K181547

FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) by Echosens — Product Code IYO

K181547 is an FDA 510(k) premarket notification submitted by Echosens for the device "FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)". The FDA issued a decision of Substantially Equivalent on Jul 9, 2018. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Echosens has 10 other 510(k) clearances on record.