FDA 510(k)

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

N.º K: K191713 · 2019-10-04

Fecha de decisión2019-10-04

Código de productoJAA

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

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

Preguntas frecuentes

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. The listed applicant is Omega Medical Imaging, LLC. The 510(k) number is K191713.

When did CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly) receive FDA 510(k) clearance?

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

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

The FDA 510(k) record lists Omega Medical Imaging, LLC as the applicant. This does not by itself establish the device manufacturer.

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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Otros registros que enlistan a Omega Medical Imaging, LLC como solicitante

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

Dispositivos relacionados (Código: JAA)

K253103Nexus DRF Digital X-ray Imaging SystemVarex Imaging Corporation K251650Insight Enhanced™ DRF (EN-1002-01)Imaging Engineering, LLC K242488Soteria E-ViewOmega Medical Imaging, LLC K242948Adora DRFi (04550010)Nrt X-Ray A/S K233380TRIDENT Mobile Fluoroscopy SystemDornier Medtech America K233945ProxiDiagnost N90 / Precision CRF (706110, 706400)Philips Medical Systems Dmc GmbH

Fuente oficial

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