Ortho Device, ADAPTIX 3D Orthopedic Imaging System
FDA 510(k) K221949 · Pausch Medical GmbH
510(k) numberK221949
Submission
- Device name
- Ortho Device, ADAPTIX 3D Orthopedic Imaging System
- Applicant
- Pausch Medical GmbH
Erlangen, DE - Received
- July 5, 2022
- Decision date
- January 26, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Ortho Device, ADAPTIX 3D Orthopedic Imaging System cleared by the FDA?
Ortho Device, ADAPTIX 3D Orthopedic Imaging System (K221949) received a 510(k) decision of Substantially Equivalent on January 26, 2023, 205 days after the submission was received.
What is the product code of K221949?
The FDA product code is IZF – System, X-Ray, Tomographic, a Class II (moderate risk) device regulated under 21 CFR 892.1740.