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510(k) K133174

ORTHOSCAN FD MINI C-ARM by Orthoscan, Inc. — Product Code OXO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 2014
Date Received
October 17, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Image-Intensified Fluoroscopic X-Ray System, Mobile
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type

Fluoroscopy of the human body.

Other clearances by Orthoscan, Inc.

  • K213113 — Orthoscan Tau Mini C-Arm (October 21, 2021)
  • K183220 — OrthoScan TAU Mini C-Arm (June 21, 2019)
  • K113708 — ORTHOSCAN MOBILE DI MINI C-ARM (January 5, 2012)
  • K051754 — ORTHOSCAN, ORTHOSCAN HD (August 9, 2005)
  • K011827 — ORTELIUS 800 (August 28, 2001)

Other clearances for product code OXO

  • K252579 — Orthoscan TAU MVP Mini C-Arm System (January 14, 2026)
  • K253269 — OEC One CFD (November 26, 2025)
  • K251004 — Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M) (November 6, 2025)
  • K250587 — Orthoscan TAU Mini C-Arm (July 2, 2025)
  • K243452 — Orthoscan VERSA Mini C-Arm (January 14, 2025)
  • K240828 — OEC One ASD (December 27, 2024)
  • K233669 — OEC 3D (March 28, 2024)
  • K213113 — Orthoscan Tau Mini C-Arm (October 21, 2021)
  • K203346 — OEC 3D (March 5, 2021)
  • K192819 — OEC Elite (November 8, 2019)