510(k) K221949

Ortho Device, ADAPTIX 3D Orthopedic Imaging System by Pausch Medical GmbH — Product Code IZF

K221949 is an FDA 510(k) premarket notification submitted by Pausch Medical GmbH for the device "Ortho Device, ADAPTIX 3D Orthopedic Imaging System". The FDA issued a decision of Substantially Equivalent on January 26, 2023. The device falls under product code IZF (System, X-Ray, Tomographic), a Class II device regulated under 21 CFR 892.1740. Pausch Medical GmbH has at least 2 other 510(k) clearances on record.