FDA 510(k) clearance · back to tracker

Ortho Device, ADAPTIX 3D Orthopedic Imaging System

Pausch Medical GmbH cleared K221949 on 2023-01-26, decision: substantially equivalent

K-number

K221949

Sponsor

Pausch Medical GmbH

Device

Ortho Device, ADAPTIX 3D Orthopedic Imaging System

Class

Class II

Decision

Substantially Equivalent

Decision date

2023-01-26

Product code

IZF

Advisory committee

Radiology

Medical specialty

Radiology

Regulation number

892.1740

Official FDA record

Open K221949on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.