FDA 510(k)

VERITON CT whole body SPECT/CT system

Número K: K182484 · 2018-11-09

RequerenteSpectrum Dynamics Medical, Ltd.

Data da decisão2018-11-09

Código do produtoKPS

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

VERITON CT whole body SPECT/CT system is the device name listed in this FDA 510(k) record. The listed applicant is Spectrum Dynamics Medical, Ltd.. It received FDA 510(k) clearance on 2018-11-09 under 510(k) number K182484. 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 VERITON CT whole body SPECT/CT system?

VERITON CT whole body SPECT/CT system is a medical device that received FDA 510(k) clearance on 2018-11-09. The listed applicant is Spectrum Dynamics Medical, Ltd.. The 510(k) number is K182484.

When did VERITON CT whole body SPECT/CT system receive FDA 510(k) clearance?

VERITON CT whole body SPECT/CT system received FDA 510(k) clearance on 2018-11-09, under 510(k) number K182484.

Who is the listed applicant for VERITON CT whole body SPECT/CT system?

The FDA 510(k) record lists Spectrum Dynamics Medical, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VERITON CT whole body SPECT/CT system?

The FDA product code for VERITON CT whole body SPECT/CT system 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 Spectrum Dynamics Medical, Ltd. como candidato(a)

K254001VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)K253532TruSPECT Processing Station K230600VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)K212230TruSPECT Radiological Image Processing Station K190457VERITON CT whole body SPECT/CT system K180514VERITON NM

Ver todos os 8 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.