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510(k) K191713

CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly) by Omega Medical Imaging, LLC — Product Code JAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 2019
Date Received
June 26, 2019
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

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  • 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)
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  • K093572 — R650 QDASM COLLIMATOR (February 3, 2010)
  • K070834 — CS-SERIES FLUOROSCOPY SYSTEM, CS-10 THROUGH CS-65 (11 CONFIGURATIONS) (May 18, 2007)
  • K062647 — E-VIEW FLUOROSCOPY SYSTEM, MODEL CS-50 (October 20, 2006)

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  • K233380 — TRIDENT Mobile Fluoroscopy System (June 26, 2024)
  • K233945 — ProxiDiagnost N90 / Precision CRF (706110, 706400) (January 11, 2024)
  • K232910 — CombiDiagnost R90 (October 19, 2023)
  • K232526 — XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 (September 12, 2023)
  • K220871 — Nautilus (April 18, 2022)
  • K212890 — Nyquist.IQ (December 13, 2021)
  • K212837 — ProxiDiagnost N90 (September 21, 2021)