FDA 510(k)

IDx-DR

N.º K: K203629 · 2021-06-10

Fecha de decisión2021-06-10

Código de productoPIB

Comité asesorOP

DecisiónSubstantially Equivalent

Resumen del dispositivo

IDx-DR is the device name listed in this FDA 510(k) record. The listed applicant is Digital Diagnostics, Inc.. It received FDA 510(k) clearance on 2021-06-10 under 510(k) number K203629. The device is classified under product code PIB. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the IDx-DR?

IDx-DR is a medical device that received FDA 510(k) clearance on 2021-06-10. The listed applicant is Digital Diagnostics, Inc.. The 510(k) number is K203629.

When did IDx-DR receive FDA 510(k) clearance?

IDx-DR received FDA 510(k) clearance on 2021-06-10, under 510(k) number K203629.

Who is the listed applicant for IDx-DR?

The FDA 510(k) record lists Digital Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IDx-DR?

The FDA product code for IDx-DR is PIB.

Otros registros que enlistan a Digital Diagnostics, Inc. 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.

K213037IDx-DR v2.3

Dispositivos relacionados (Código: PIB)

K253704iPredict-DRiHealthscreen, Inc.K240058AEYE-DSAeye Health, Inc.K223357EyeArt v2.2.0Eyenuk, Inc.K221183AEYE-DSAeye Health, Inc.K213037IDx-DR v2.3Digital Diagnostics, Inc.K200667EyeArtEyenuk, 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.