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510(k) K243303

Ziehm Vision RFD 3D by Ziehm Imaging GmbH — Product Code OWB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 2025
Date Received
October 21, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Interventional Fluoroscopic X-Ray System
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type

Interventional fluoroscopy

Other clearances by Ziehm Imaging GmbH

  • K243646 — Ziehm Solo FD (March 17, 2025)
  • K243735 — Ziehm Vision FD (March 13, 2025)
  • K243328 — Ziehm Vision RFD (January 15, 2025)
  • K240099 — Ziehm Vision RFD (February 5, 2024)
  • K240020 — Ziehm Vision FD (January 30, 2024)
  • K234109 — Ziehm Solo FD (January 26, 2024)
  • K231700 — Ziehm Vision FD (December 15, 2023)
  • K231669 — Ziehm Solo FD (December 12, 2023)
  • K231692 — Ziehm Vision RFD (November 20, 2023)
  • K231701 — Ziehm Vision RFD 3D (July 10, 2023)

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