FDA 510(k)

I-Q View

Número K: K203703 · 2021-03-24

Data da decisão2021-03-24

Código do produtoMQB

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

I-Q View is the device name listed in this FDA 510(k) record. The listed applicant is First Source, Inc.. It received FDA 510(k) clearance on 2021-03-24 under 510(k) number K203703. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the I-Q View?

I-Q View is a medical device that received FDA 510(k) clearance on 2021-03-24. The listed applicant is First Source, Inc.. The 510(k) number is K203703.

When did I-Q View receive FDA 510(k) clearance?

I-Q View received FDA 510(k) clearance on 2021-03-24, under 510(k) number K203703.

Who is the listed applicant for I-Q View?

The FDA 510(k) record lists First Source, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for I-Q View?

The FDA product code for I-Q View is MQB.

Outros registros que listam First Source, Inc. como candidato(a)

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.

K240009iQFlex Pro K221081iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System

Dispositivos Relacionados (Código: MQB)

K2538000909FCE, 0909FCE-HSRayence Co., Ltd.K260820VIVIX-S 4386W (FXRD-4386WA)Vieworks Co., Ltd.K252996Universal 1417PIKonica Minolta Healthcare Americas, Inc.K252911Lux HD 2530 detector (Lux HD 2530)Iray Imaging Technology (Haining) Limited K250211Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp.K250665SKR 3000Konica Minolta, Inc.

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.