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510(k) K193230

Ziehm Vision FD by Ziehm Imaging GmbH — Product Code OWB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2019
Date Received
November 25, 2019
Clearance Type
Special
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

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  • 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)

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