FDA 510(k)

Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert

N.º K: K213642 · 2022-01-13

Fecha de decisión2022-01-13

Código de productoIYN

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare. It received FDA 510(k) clearance on 2022-01-13 under 510(k) number K213642. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert?

Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert is a medical device that received FDA 510(k) clearance on 2022-01-13. The listed applicant is GE Healthcare. The 510(k) number is K213642.

When did Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert receive FDA 510(k) clearance?

Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert received FDA 510(k) clearance on 2022-01-13, under 510(k) number K213642.

Who is the listed applicant for Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert?

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

What is the FDA product code for Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert?

The FDA product code for Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert is IYN.

Ensayos clínicos relacionados

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Otros registros que enlistan a GE Healthcare como solicitante

K253639View K242925MR Contour DL K232346Digital Expert Access with Remote Scanning K223212Precision DL K221680Xeleris V Processing and Review System K221932Omni Legend

Ver todos los 55 dispositivos →

Dispositivos relacionados (Código: IYN)

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.