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510(k) K070834

CS-SERIES FLUOROSCOPY SYSTEM, CS-10 THROUGH CS-65 (11 CONFIGURATIONS) by Omega Medical Imaging, Inc. — Product Code OWB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 2007
Date Received
March 27, 2007
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

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  • K191713 — CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroS (October 4, 2019)
  • K182834 — CS-series-FP with Optional ROI Accessory CA-100S (March 29, 2019)
  • K171755 — CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy Sys (February 9, 2018)
  • K121293 — CS-SERIES-FP WITH 3030+OPTION (July 26, 2012)
  • K100102 — CS-SERIES-FP (August 31, 2010)
  • K093572 — R650 QDASM COLLIMATOR (February 3, 2010)
  • K062647 — E-VIEW FLUOROSCOPY SYSTEM, MODEL CS-50 (October 20, 2006)

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  • K251893 — SKAN C PULSAR (December 16, 2025)
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  • K251827 — Azurion R3.1 (October 24, 2025)
  • K251602 — Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (October 10, 2025)