FDA 510(k), K191713, CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly)

FDA 510(k), K191713, CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly)

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510(K) Number: K191713
Device Name: CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly)
Manufacturer: Omega Medical Imaging, LLC
Device Classification Name: system, x-ray, fluoroscopic, image-intensified
Regulation Number: 892.1650
Classification Product Code: JAA
Date Received: 06/26/2019
Decision Date: 10/04/2019
Regulation Medical Specialty: Radiology

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