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510(k) K021049

OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEM by Ge Oec Medical Systems — Product Code OWB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2002
Date Received
April 1, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Interventional Fluoroscopic X-Ray System
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type

Interventional fluoroscopy

Other clearances by Ge Oec Medical Systems

  • K233669 — OEC 3D (March 28, 2024)
  • K203346 — OEC 3D (March 5, 2021)
  • K192819 — OEC Elite (November 8, 2019)
  • 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)

Other clearances for product code OWB

  • K253584 — Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension) (March 10, 2026)
  • K252500 — CARA System (February 20, 2026)
  • K251992 — ArmSure Fluoroscopic Positioning System (February 11, 2026)
  • K254186 — Azurion R3.1 (January 16, 2026)
  • K252068 — MC2 Portable X-ray System (December 22, 2025)
  • K251893 — SKAN C PULSAR (December 16, 2025)
  • K251199 — Allia Moveo (December 9, 2025)
  • K250241 — Cios Select (November 4, 2025)
  • K251827 — Azurion R3.1 (October 24, 2025)
  • K251602 — Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (October 10, 2025)