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
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
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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