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510(k) K213113

Orthoscan Tau Mini C-Arm by Orthoscan, Inc. — Product Code OXO

K213113 is an FDA 510(k) premarket notification submitted by Orthoscan, Inc. for the device "Orthoscan Tau Mini C-Arm". The FDA issued a decision of Substantially Equivalent on October 21, 2021. The device falls under product code OXO (Image-Intensified Fluoroscopic X-Ray System, Mobile), a Class II device regulated under 21 CFR 892.1650. Orthoscan, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 2021
Date Received
September 27, 2021
Clearance Type
Special
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.

  • K183220 — OrthoScan TAU Mini C-Arm (June 21, 2019)
  • K133174 — ORTHOSCAN FD MINI C-ARM (March 28, 2014)
  • 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

  • K253296 — Digital C-ARM with 3D (June 5, 2026)
  • 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)
  • K203346 — OEC 3D (March 5, 2021)
  • K192819 — OEC Elite (November 8, 2019)

FDA data resources