FDA 510(k)

Voluson™ Performance 16; Voluson™ Performance 18

N.º K: K250543 · 2025-05-29

SolicitanteGE Medical Systems Ultrasound and Primary Care Diagnostics

Fecha de decisión2025-05-29

Código de productoIYN

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

Voluson™ Performance 16; Voluson™ Performance 18 is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems Ultrasound and Primary Care Diagnostics. It received FDA 510(k) clearance on 2025-05-29 under 510(k) number K250543. 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™ Performance 16; Voluson™ Performance 18?

Voluson™ Performance 16; Voluson™ Performance 18 is a medical device that received FDA 510(k) clearance on 2025-05-29. The listed applicant is GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K250543.

When did Voluson™ Performance 16; Voluson™ Performance 18 receive FDA 510(k) clearance?

Voluson™ Performance 16; Voluson™ Performance 18 received FDA 510(k) clearance on 2025-05-29, under 510(k) number K250543.

Who is the listed applicant for Voluson™ Performance 16; Voluson™ Performance 18?

The FDA 510(k) record lists GE Medical Systems Ultrasound and Primary Care Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Voluson™ Performance 16; Voluson™ Performance 18?

The FDA product code for Voluson™ Performance 16; Voluson™ Performance 18 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 Medical Systems Ultrasound and Primary Care Diagnostics como solicitante

K261623EchoPAC Software Only / EchoPAC Plug-in (v211)K261313Vivid Explorer/Vivid Advanced/Vivid Focus K261835LOGIQ Focus K260398LOGIQ e K260673LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power K253370LOGIQ Totus

Ver todos los 65 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.