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510(k) K192819

OEC Elite by Ge Oec Medical Systems, Inc. — Product Code OXO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 2019
Date Received
October 1, 2019
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 Oec Medical Systems, Inc.

  • K233669 — OEC 3D (March 28, 2024)
  • K203346 — OEC 3D (March 5, 2021)
  • K172550 — OEC Elite (November 16, 2017)
  • K171565 — OEC Elite (August 10, 2017)
  • K132027 — OEC 9800 PLUS (May 1, 2014)
  • K111551 — OEC(R) 9800, OEC(R) 9800 PLUS (October 4, 2011)
  • K073543 — OEC 9900 ELITE (May 2, 2008)
  • K061953 — 9900 PLUS MOBILE FLUOROSCOPY SYSTEM WITH 3D AND NAVIGATION OPTIONS (August 15, 2006)
  • K052039 — GE OEC ALTITUDE (August 11, 2005)
  • K051490 — GE OEC EVERVIEW 7500 (July 7, 2005)

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)
  • K190024 — Smart-C (September 27, 2019)