FDA 510(k)

HALO AP Dx

N.º K: K252762 · 2025-11-25

Fecha de decisión2025-11-25

Código de productoQKQ

Comité asesorPA

DecisiónSubstantially Equivalent

Resumen del dispositivo

HALO AP Dx is the device name listed in this FDA 510(k) record. The listed applicant is Indica Labs, LLC. It received FDA 510(k) clearance on 2025-11-25 under 510(k) number K252762. The device is classified under product code QKQ. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the HALO AP Dx?

HALO AP Dx is a medical device that received FDA 510(k) clearance on 2025-11-25. The listed applicant is Indica Labs, LLC. The 510(k) number is K252762.

When did HALO AP Dx receive FDA 510(k) clearance?

HALO AP Dx received FDA 510(k) clearance on 2025-11-25, under 510(k) number K252762.

Who is the listed applicant for HALO AP Dx?

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

What is the FDA product code for HALO AP Dx?

The FDA product code for HALO AP Dx is QKQ.

Dispositivos relacionados (Código: QKQ)

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.

K261380Concentriq AP-DxProscia, Inc.K243449INFINITT DPSInfinitt Healthcare Co., Ltd.K243391AISight DxPathAI, Inc.K250968PathPresenter Clinical ViewerPathpresenter Corporation K250414CaloPixTribun Health K242244Viewer+Lumea, Inc.

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.