Home / 510(k) Clearances / K052039

510(k) K052039

GE OEC ALTITUDE by Ge Oec Medical Systems — Product Code IZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 2005
Date Received
July 28, 2005
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Angiographic
Device Class
Class II
Regulation Number
892.1600
Review Panel
RA
Submission Type

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)
  • K051490 — GE OEC EVERVIEW 7500 (July 7, 2005)

Other clearances for product code IZI

  • K243645 — IC-Flow™ Imaging System 2.0 (September 22, 2025)
  • K243077 — Affirm 800 (June 27, 2025)
  • K231986 — Modus IR (March 25, 2024)
  • K234090 — EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004) (March 20, 2024)
  • K231075 — Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option) (June 20, 2023)
  • K230727 — SPY Portable Handheld Imaging (SPY-PHI) System (June 5, 2023)
  • K222240 — EXPLORER AIR® II (February 28, 2023)
  • K214097 — Explorer Air II (February 25, 2022)
  • K202391 — DIR 800 (January 21, 2021)
  • K192761 — Asimov-MKS Imaging System (January 17, 2020)