Home / 510(k) Clearances / K161976

510(k) K161976

Ziehm Solo FD by Ziehm Imaging GmbH — Product Code OWB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 2016
Date Received
July 18, 2016
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)
  • K243303 — Ziehm Vision RFD 3D (January 21, 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)

Other clearances for product code OWB

  • K253584 — Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension) (March 10, 2026)
  • K252500 — CARA System (February 20, 2026)
  • K251992 — ArmSure Fluoroscopic Positioning System (February 11, 2026)
  • K254186 — Azurion R3.1 (January 16, 2026)
  • K252068 — MC2 Portable X-ray System (December 22, 2025)
  • K251893 — SKAN C PULSAR (December 16, 2025)
  • K251199 — Allia Moveo (December 9, 2025)
  • K250241 — Cios Select (November 4, 2025)
  • K251827 — Azurion R3.1 (October 24, 2025)
  • K251602 — Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (October 10, 2025)