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FDA 510(k)

Ortho Device, ADAPTIX 3D Orthopedic Imaging System

K-Number: K221949 · 2023-01-26

ApplicantPausch Medical GmbH
Decision Date2023-01-26
Product CodeIZF
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Ortho Device, ADAPTIX 3D Orthopedic Imaging System is a medical device manufactured by Pausch Medical GmbH. It received FDA 510(k) clearance on 2023-01-26 under approval number K221949. The device is classified under product code IZF. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ortho Device, ADAPTIX 3D Orthopedic Imaging System?

Ortho Device, ADAPTIX 3D Orthopedic Imaging System is a medical device that received FDA 510(k) clearance on 2023-01-26. It is manufactured by Pausch Medical GmbH. The 510(k) number is K221949.

When was Ortho Device, ADAPTIX 3D Orthopedic Imaging System approved by the FDA?

Ortho Device, ADAPTIX 3D Orthopedic Imaging System received FDA 510(k) clearance on 2023-01-26, under approval number K221949.

What company makes Ortho Device, ADAPTIX 3D Orthopedic Imaging System?

Ortho Device, ADAPTIX 3D Orthopedic Imaging System is manufactured by Pausch Medical GmbH.

What is the FDA product code for Ortho Device, ADAPTIX 3D Orthopedic Imaging System?

The FDA product code for Ortho Device, ADAPTIX 3D Orthopedic Imaging System is IZF.

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Related PubMed Literature

PMID: 42204020 A Minimal UDI-DICOM Mapping Profile and Validation Artifact for Medical-Device Imaging Workflows. Journal of imaging informatics in medicine (2026) PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026)

Other Devices by Pausch Medical GmbH

K161019Uroview FD K180651Uroview FD II

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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