FDA 510(k)

ApolloVue S100 Image System

Número K: K201552 · 2020-09-02

Data da decisão2020-09-02

Código do produtoNQQ

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

ApolloVue S100 Image System is the device name listed in this FDA 510(k) record. The listed applicant is Apollo Medical Optics, Ltd.. It received FDA 510(k) clearance on 2020-09-02 under 510(k) number K201552. The device is classified under product code NQQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ApolloVue S100 Image System?

ApolloVue S100 Image System is a medical device that received FDA 510(k) clearance on 2020-09-02. The listed applicant is Apollo Medical Optics, Ltd.. The 510(k) number is K201552.

When did ApolloVue S100 Image System receive FDA 510(k) clearance?

ApolloVue S100 Image System received FDA 510(k) clearance on 2020-09-02, under 510(k) number K201552.

Who is the listed applicant for ApolloVue S100 Image System?

The FDA 510(k) record lists Apollo Medical Optics, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ApolloVue S100 Image System?

The FDA product code for ApolloVue S100 Image System is NQQ.

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

Dispositivos Relacionados (Código: NQQ)

K253459OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)ABBOTT MEDICAL K251730LIA Console (542-7)Leadoptik, Inc.K253101HyperVue™ Imaging System - IntegratedSpectrawave, Inc.K252851deepLive (OSP12 + DMS)Damae Medical K251198HyperVue™ SoftwareSpectrawave, Inc.K250684OPUSWAVE Dual Sensor Imaging SystemTerumo Cardiovascular Systems Thi Plant

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.