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510(k) K251004

Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M) by Hefei Chimed Intelligent Machine Co., Ltd. — Product Code OXO

K251004 is an FDA 510(k) premarket notification submitted by Hefei Chimed Intelligent Machine Co., Ltd. for the device "Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)". The FDA issued a decision of Substantially Equivalent on November 6, 2025. The device falls under product code OXO (Image-Intensified Fluoroscopic X-Ray System, Mobile), a Class II device regulated under 21 CFR 892.1650.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 2025
Date Received
April 1, 2025
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 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)
  • 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)

FDA data resources