FDA 510(k)

CT:VQ

N.º K: K251484 · 2025-08-28

Fecha de decisión2025-08-28

Código de productoJAK

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

CT:VQ is the device name listed in this FDA 510(k) record. The listed applicant is 4Dmedical Limited. It received FDA 510(k) clearance on 2025-08-28 under 510(k) number K251484. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the CT:VQ?

CT:VQ is a medical device that received FDA 510(k) clearance on 2025-08-28. The listed applicant is 4Dmedical Limited. The 510(k) number is K251484.

When did CT:VQ receive FDA 510(k) clearance?

CT:VQ received FDA 510(k) clearance on 2025-08-28, under 510(k) number K251484.

Who is the listed applicant for CT:VQ?

The FDA 510(k) record lists 4Dmedical Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CT:VQ?

The FDA product code for CT:VQ is JAK.

Otros registros que enlistan a 4Dmedical Limited como solicitante

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K232392CT Lung Ventilation Analysis Software (CT:V)

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

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.