510(k) K203658

Micro C Medical Imaging System, M01 by Oxos Medical, Inc. — Product Code IZL

K203658 is an FDA 510(k) premarket notification submitted by Oxos Medical, Inc. for the device "Micro C Medical Imaging System, M01". The FDA issued a decision of Substantially Equivalent on January 12, 2021. The device falls under product code IZL (System, X-Ray, Mobile), a Class II device regulated under 21 CFR 892.1720. Oxos Medical, Inc. has at least 4 other 510(k) clearances on record.