FDA 510(k)

Photonova Spectra, Photonova Spectra Select

Número K: K253520 · 2026-03-20

Data da decisão2026-03-20

Código do produtoJAK

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Photonova Spectra, Photonova Spectra Select is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2026-03-20 under 510(k) number K253520. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Photonova Spectra, Photonova Spectra Select?

Photonova Spectra, Photonova Spectra Select is a medical device that received FDA 510(k) clearance on 2026-03-20. The listed applicant is Ge Medical Systems, LLC. The 510(k) number is K253520.

When did Photonova Spectra, Photonova Spectra Select receive FDA 510(k) clearance?

Photonova Spectra, Photonova Spectra Select received FDA 510(k) clearance on 2026-03-20, under 510(k) number K253520.

Who is the listed applicant for Photonova Spectra, Photonova Spectra Select?

The FDA 510(k) record lists Ge Medical Systems, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Photonova Spectra, Photonova Spectra Select?

The FDA product code for Photonova Spectra, Photonova Spectra Select is JAK.

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 Ge Medical Systems, LLC como candidato(a)

K253560Enhanced Boundary for PCCT K253502Critical Care Suite with Enteric Tube Positioning AI Algorithm K253780SIGNA™ Bolt K253779SIGNA™ Sprint Select K252379AIR Recon DL K251399SIGNA™ Sprint

Ver todos os 43 dispositivos →

Dispositivos Relacionados (Código: JAK)

K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.K261229SCENARIA View Phase 6.0Fujifilm Corporation K253836FCT iStream Phase 2Fujifilm Corporation K253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung Company K253770CardIQ SuiteGE Medical Systems SCS K253560Enhanced Boundary for PCCTGe Medical Systems, LLC

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.