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510(k) K171800

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 2017
Date Received
June 16, 2017
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 Ge Hualun Medical Systems Co. , Ltd.

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  • K191699 — Discovery XR656 HD with VolumeRad (July 24, 2019)
  • K182626 — OEC One (November 16, 2018)
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Other clearances for product code OXO

  • K252579 — Orthoscan TAU MVP Mini C-Arm System (January 14, 2026)
  • K253269 — OEC One CFD (November 26, 2025)
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  • 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)