FDA 510(k)

Paragon XHD Diagnostic Ultrasound System

N.º K: K191347 · 2020-02-07

SolicitanteShenzhen Wisonic Medical Technology Co. , Ltd.

Fecha de decisión2020-02-07

Código de productoIYN

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

Paragon XHD Diagnostic Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Wisonic Medical Technology Co. , Ltd.. It received FDA 510(k) clearance on 2020-02-07 under 510(k) number K191347. 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 Paragon XHD Diagnostic Ultrasound System?

Paragon XHD Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2020-02-07. The listed applicant is Shenzhen Wisonic Medical Technology Co. , Ltd.. The 510(k) number is K191347.

When did Paragon XHD Diagnostic Ultrasound System receive FDA 510(k) clearance?

Paragon XHD Diagnostic Ultrasound System received FDA 510(k) clearance on 2020-02-07, under 510(k) number K191347.

Who is the listed applicant for Paragon XHD Diagnostic Ultrasound System?

The FDA 510(k) record lists Shenzhen Wisonic Medical Technology Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Paragon XHD Diagnostic Ultrasound System?

The FDA product code for Paragon XHD Diagnostic Ultrasound System 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 Shenzhen Wisonic Medical Technology Co. , Ltd. como solicitante

K230066Carnation series Diagnostic Ultrasound System K211886Clivia series Diagnostic Ultrasound System K210154Labat series Diagnostic Ultrasound System K182715Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound System K180461Navi e/Navi s/Navi X Diagnostic Ultrasound System K163712Clover 50/Clover60/Clover70 Diagnostic Ultrasound System

Ver todos los 7 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.