FDA 510(k)

ArteraAI Breast

Número K: K254115 · 2026-05-04

Data da decisão2026-05-04

Código do produtoSHW

Comité consultivoPA

DecisãoSubstantially Equivalent

Resumo do dispositivo

ArteraAI Breast is the device name listed in this FDA 510(k) record. The listed applicant is Artera, Inc.. It received FDA 510(k) clearance on 2026-05-04 under 510(k) number K254115. The device is classified under product code SHW. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ArteraAI Breast?

ArteraAI Breast is a medical device that received FDA 510(k) clearance on 2026-05-04. The listed applicant is Artera, Inc.. The 510(k) number is K254115.

When did ArteraAI Breast receive FDA 510(k) clearance?

ArteraAI Breast received FDA 510(k) clearance on 2026-05-04, under 510(k) number K254115.

Who is the listed applicant for ArteraAI Breast?

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

What is the FDA product code for ArteraAI Breast?

The FDA product code for ArteraAI Breast is SHW.

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: SHW)

K260023TumorSight RiskSimBioSys, 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.