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510(k) K182626

OEC One by Ge Hualun Medical Systems Co. , Ltd. — Product Code OXO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 2018
Date Received
September 24, 2018
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 Ge Hualun Medical Systems Co. , Ltd.

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  • K242678 — Definium Pace Select ET (October 1, 2024)
  • K231892 — Definium Pace Select (September 12, 2023)
  • K191699 — Discovery XR656 HD with VolumeRad (July 24, 2019)
  • K173612 — Optima XR646 HD (December 11, 2017)
  • K172700 — OEC One (November 9, 2017)
  • K172869 — Discovery XR656 HD (October 20, 2017)
  • K171800 — OEC Elite MiniView (July 12, 2017)

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)