510(k) K213254

Axialis Ophthalmic Ultrasound System by Quantel Medical — Product Code IYO

K213254 is an FDA 510(k) premarket notification submitted by Quantel Medical for the device "Axialis Ophthalmic Ultrasound System". The FDA issued a decision of Substantially Equivalent on November 15, 2021. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Quantel Medical has at least 10 other 510(k) clearances on record.