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FDA 510(k)

CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly)

K-Number: K191713 · 2019-10-04

ApplicantOmega Medical Imaging, LLC
Decision Date2019-10-04
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly) is a medical device manufactured by Omega Medical Imaging, LLC. It received FDA 510(k) clearance on 2019-10-04 under approval number K191713. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly)?

CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly) is a medical device that received FDA 510(k) clearance on 2019-10-04. It is manufactured by Omega Medical Imaging, LLC. The 510(k) number is K191713.

When was CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly) approved by the FDA?

CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly) received FDA 510(k) clearance on 2019-10-04, under approval number K191713.

What company makes CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly)?

CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly) is manufactured by Omega Medical Imaging, LLC.

What is the FDA product code for CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly)?

The FDA product code for CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly) is JAA.

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Other Devices by Omega Medical Imaging, LLC

K171755CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System K182834CS-series-FP with Optional ROI Accessory CA-100S K212890Nyquist.IQ K212336Soteria.AI K242488Soteria E-View

Related Devices (Code: JAA)

K161019Uroview FDPausch Medical GmbH K160301Platinum dRF Imaging SystemApelem-Dms Group K163210Philips CombiDiagnost R90Philips Medical Systems Dmc GmbH K173395MECALL CLISIS SYSTEMS, Discovery RF180General Medical Merate S.P.A K180651Uroview FD IIPausch Medical GmbH K180589DR 800 with MUSICA DynamicAgfa Healthcare N.V.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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