FDA 510(k)

Symbia SPECT and SPECT/CT Systems

Número K: K241898 · 2024-07-26

Data da decisão2024-07-26

Código do produtoKPS

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Symbia SPECT and SPECT/CT Systems is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthineers. It received FDA 510(k) clearance on 2024-07-26 under 510(k) number K241898. 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 Symbia SPECT and SPECT/CT Systems?

Symbia SPECT and SPECT/CT Systems is a medical device that received FDA 510(k) clearance on 2024-07-26. The listed applicant is Siemens Healthineers. The 510(k) number is K241898.

When did Symbia SPECT and SPECT/CT Systems receive FDA 510(k) clearance?

Symbia SPECT and SPECT/CT Systems received FDA 510(k) clearance on 2024-07-26, under 510(k) number K241898.

Who is the listed applicant for Symbia SPECT and SPECT/CT Systems?

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

What is the FDA product code for Symbia SPECT and SPECT/CT Systems?

The FDA product code for Symbia SPECT and SPECT/CT Systems 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 Siemens Healthineers como candidato(a)

K183575Sistema de Ultrassonografia Diagnóstica ACUSON S3000, S2000

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.