FDA 510(k)

4DM

N.º K: K260879 · 2026-09-10

Fecha de decisión2026-09-10

Código de productoQIH

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

4DM is the device name listed in this FDA 510(k) record. The listed applicant is INVIA, LLC. It received FDA 510(k) clearance on 2026-09-10 under 510(k) number K260879. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the 4DM?

4DM is a medical device that received FDA 510(k) clearance on 2026-09-10. The listed applicant is INVIA, LLC. The 510(k) number is K260879.

When did 4DM receive FDA 510(k) clearance?

4DM received FDA 510(k) clearance on 2026-09-10, under 510(k) number K260879.

Who is the listed applicant for 4DM?

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

What is the FDA product code for 4DM?

The FDA product code for 4DM is QIH.

Dispositivos relacionados (Código: QIH)

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.

K260055syngo.CT Brain QuantificationSiemens Medical Solutions USA, Inc.K262390BoneXpertVisiana K261368Rapid Platform (R6.7)Ischemaview, Inc.K261623EchoPAC Software Only / EchoPAC Plug-in (v211)GE Medical Systems Ultrasound and Primary Care Diagnostics K261677Artificial Intelligence Renal Assessment (AIRA) Version 1Aramis Global AI Consultancies, LLC K261795Quicktome Software SuiteOmniscient Neurotechnology Pty, Ltd.

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.