FDA 510(k)

CTXX85

Número K: K182147 · 2018-09-07

Data da decisão2018-09-07

Código do produtoJAK

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

CTXX85 is the device name listed in this FDA 510(k) record. The listed applicant is Analogic Corporation. It received FDA 510(k) clearance on 2018-09-07 under 510(k) number K182147. 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 CTXX85?

CTXX85 is a medical device that received FDA 510(k) clearance on 2018-09-07. The listed applicant is Analogic Corporation. The 510(k) number is K182147.

When did CTXX85 receive FDA 510(k) clearance?

CTXX85 received FDA 510(k) clearance on 2018-09-07, under 510(k) number K182147.

Who is the listed applicant for CTXX85?

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

What is the FDA product code for CTXX85?

The FDA product code for CTXX85 is JAK.

Outros registros que listam Analogic Corporation como candidato(a)

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.

K201231CTxx85 CT Scanner K172058CT6485, CT12885 K161342Sonic Window

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.