FDA 510(k)

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

Número K: K191713 · 2019-10-04

Data da decisão2019-10-04

Código do produtoJAA

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Outros registros que listam Omega Medical Imaging, LLC como candidato(a)

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

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.