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510(k) K024012

OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM by Ge Oec Medical Systems — Product Code JAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2003
Date Received
December 4, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Ge Oec Medical Systems

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  • 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)

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  • K233380 — TRIDENT Mobile Fluoroscopy System (June 26, 2024)
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  • K232910 — CombiDiagnost R90 (October 19, 2023)
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  • K220871 — Nautilus (April 18, 2022)
  • K212890 — Nyquist.IQ (December 13, 2021)
  • K212837 — ProxiDiagnost N90 (September 21, 2021)