FDA 510(k)

Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)

Número K: K241554 · 2024-10-24

RequerenteTelefield Medical Imaging (Shenzhen) Limited

Data da decisão2024-10-24

Código do produtoIYN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L) is the device name listed in this FDA 510(k) record. The listed applicant is Telefield Medical Imaging (Shenzhen) Limited. It received FDA 510(k) clearance on 2024-10-24 under 510(k) number K241554. 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 Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)?

Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L) is a medical device that received FDA 510(k) clearance on 2024-10-24. The listed applicant is Telefield Medical Imaging (Shenzhen) Limited. The 510(k) number is K241554.

When did Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L) receive FDA 510(k) clearance?

Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L) received FDA 510(k) clearance on 2024-10-24, under 510(k) number K241554.

Who is the listed applicant for Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)?

The FDA 510(k) record lists Telefield Medical Imaging (Shenzhen) Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)?

The FDA product code for Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L) 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

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.