510(k) K221803

PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress. by Sedecal., Sa. — Product Code IZL

K221803 is an FDA 510(k) premarket notification submitted by Sedecal., Sa. for the device "PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress.". The FDA issued a decision of Substantially Equivalent on July 18, 2022. The device falls under product code IZL (System, X-Ray, Mobile), a Class II device regulated under 21 CFR 892.1720. Sedecal., Sa. has at least 10 other 510(k) clearances on record.