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510(k) K221949

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 2023
Date Received
July 5, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Tomographic
Device Class
Class II
Regulation Number
892.1740
Review Panel
RA
Submission Type

Other clearances by Pausch Medical GmbH

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  • K161019 — Uroview FD (August 17, 2016)

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  • K242395 — Nanox.ARC (December 4, 2024)
  • K222934 — Nanox.ARC (April 28, 2023)
  • K213081 — CLISIS SYSTEMS, Discovery RF180 (October 26, 2021)
  • K193262 — DR 600 with Tomosynthesis (March 9, 2020)
  • K183275 — DR 800 with Tomosynthesis (February 1, 2019)
  • K132261 — DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS) (November 18, 2013)
  • K121499 — FUJIFILM TOMOSYNTHESIS OPTION FOR FDR ACSELERATE STATIONARY X-RAY SYSTEM (November 20, 2012)