FDA 510(k)

Butterfly iQ Ultrasound System

Número K: K202406 · 2020-09-16

Data da decisão2020-09-16

Código do produtoIYN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Butterfly iQ Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Butterfly Network, Inc.. It received FDA 510(k) clearance on 2020-09-16 under 510(k) number K202406. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Butterfly iQ Ultrasound System?

Butterfly iQ Ultrasound System is a medical device that received FDA 510(k) clearance on 2020-09-16. The listed applicant is Butterfly Network, Inc.. The 510(k) number is K202406.

When did Butterfly iQ Ultrasound System receive FDA 510(k) clearance?

Butterfly iQ Ultrasound System received FDA 510(k) clearance on 2020-09-16, under 510(k) number K202406.

Who is the listed applicant for Butterfly iQ Ultrasound System?

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

What is the FDA product code for Butterfly iQ Ultrasound System?

The FDA product code for Butterfly iQ Ultrasound System is IYN.

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 Butterfly Network, Inc. como candidato(a)

K252148Butterfly Gestational Age Tool K232808Butterfly iQ3 Ultrasound System K220068Butterfly iQ/iQ+ Ultrasound System K200980Auto 3D Bladder Volume Tool K163510Poseidon Ultrasound System

Dispositivos Relacionados (Código: IYN)

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.