FDA 510(k)

Hermes Medical Imaging Suite v5.6

Número K: K153056 · 2016-06-01

Data da decisão2016-06-01

Código do produtoKPS

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Hermes Medical Imaging Suite v5.6 is the device name listed in this FDA 510(k) record. The listed applicant is Hermes Medical Solutions AB. It received FDA 510(k) clearance on 2016-06-01 under 510(k) number K153056. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Hermes Medical Imaging Suite v5.6?

Hermes Medical Imaging Suite v5.6 is a medical device that received FDA 510(k) clearance on 2016-06-01. The listed applicant is Hermes Medical Solutions AB. The 510(k) number is K153056.

When did Hermes Medical Imaging Suite v5.6 receive FDA 510(k) clearance?

Hermes Medical Imaging Suite v5.6 received FDA 510(k) clearance on 2016-06-01, under 510(k) number K153056.

Who is the listed applicant for Hermes Medical Imaging Suite v5.6?

The FDA 510(k) record lists Hermes Medical Solutions AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hermes Medical Imaging Suite v5.6?

The FDA product code for Hermes Medical Imaging Suite v5.6 is KPS.

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 Hermes Medical Solutions AB como candidato(a)

K253835Affinity K252477Hybrid Viewer (00859873006240)K243919Voxel Dosimetry (00859873006226)K241364Hybrid Viewer (00859873006189)K202882Affinity K193152Affinity

Ver todos os 13 dispositivos →

Dispositivos Relacionados (Código: KPS)

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.