Cleared Traditional

Ortho Device, ADAPTIX 3D Orthopedic Imaging System

K221949 · Pausch Medical GmbH · Radiology
Jan 2023
Decision
205d
Days
Class 2
Risk

About This 510(k) Submission

K221949 is an FDA 510(k) clearance for the Ortho Device, ADAPTIX 3D Orthopedic Imaging System, a System, X-ray, Tomographic (Class II — Special Controls, product code IZF), submitted by Pausch Medical GmbH (Erlangen, DE). The FDA issued a Cleared decision on January 26, 2023, 205 days after receiving the submission on July 5, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1740.

Submission Details

510(k) Number K221949 FDA.gov
FDA Decision Cleared SESE
Date Received July 05, 2022
Decision Date January 26, 2023
Days to Decision 205 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IZF — System, X-ray, Tomographic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1740