510(k) K211098

Breast Volume Navigator (BVN) Model G-2000 by Metritrack, Inc. — Product Code IYO

K211098 is an FDA 510(k) premarket notification submitted by Metritrack, Inc. for the device "Breast Volume Navigator (BVN) Model G-2000". The FDA issued a decision of Substantially Equivalent on May 26, 2021. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Metritrack, Inc. has 1 other 510(k) clearance on record.