FDA 510(k)

Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1

Número K: K153206 · 2016-03-03

RequerenteFujifilm Medical System U.S.A., Inc.

Data da decisão2016-03-03

Código do produtoFDS

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1 is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Medical System U.S.A., Inc.. It received FDA 510(k) clearance on 2016-03-03 under 510(k) number K153206. The device is classified under product code FDS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1?

Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1 is a medical device that received FDA 510(k) clearance on 2016-03-03. The listed applicant is Fujifilm Medical System U.S.A., Inc.. The 510(k) number is K153206.

When did Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1 receive FDA 510(k) clearance?

Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1 received FDA 510(k) clearance on 2016-03-03, under 510(k) number K153206.

Who is the listed applicant for Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1?

The FDA 510(k) record lists Fujifilm Medical System U.S.A., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1?

The FDA product code for Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1 is FDS.

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 Fujifilm Medical System U.S.A., Inc. como candidato(a)

K163675Processor VP-7000, Light Source BL-7000 K151474Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)

Dispositivos Relacionados (Código: FDS)

K261400Ambu® aScope™ Gastro; Ambu® aScope™ Gastro LargeAmbu A/S K260824Gastrointestinal Videoscope Olympus GIF-2T1500Olympus Medical Systems Corporation K260856Disposable Distal Attachment D-201-13404Olympus Medical Systems Corporation K253702Intuitive Endoluminal Gastrointestinal System (IG1000)Intuitive Surgical, Inc.K260573EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.K250550FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display UnitFujifilm Corporation

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.