FDA 510(k)

ExactVu High Resolution Micro-Ultrasound System

N.º K: K162972 · 2016-12-02

Fecha de decisión2016-12-02

Código de productoIYO

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

ExactVu High Resolution Micro-Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Exact Imaging. It received FDA 510(k) clearance on 2016-12-02 under 510(k) number K162972. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the ExactVu High Resolution Micro-Ultrasound System?

ExactVu High Resolution Micro-Ultrasound System is a medical device that received FDA 510(k) clearance on 2016-12-02. The listed applicant is Exact Imaging. The 510(k) number is K162972.

When did ExactVu High Resolution Micro-Ultrasound System receive FDA 510(k) clearance?

ExactVu High Resolution Micro-Ultrasound System received FDA 510(k) clearance on 2016-12-02, under 510(k) number K162972.

Who is the listed applicant for ExactVu High Resolution Micro-Ultrasound System?

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

What is the FDA product code for ExactVu High Resolution Micro-Ultrasound System?

The FDA product code for ExactVu High Resolution Micro-Ultrasound System is IYO.

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

Dispositivos relacionados (Código: IYO)

K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApS K252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, 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.