FDA 510(k)

Vivid Pioneer

Número K: K251169 · 2025-07-10

RequerenteGE Medical Systems Ultrasound and Primary Care Diagnostics

Data da decisão2025-07-10

Código do produtoIYN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Vivid Pioneer 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 2025-07-10 under 510(k) number K251169. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Vivid Pioneer?

Vivid Pioneer is a medical device that received FDA 510(k) clearance on 2025-07-10. The listed applicant is GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K251169.

When did Vivid Pioneer receive FDA 510(k) clearance?

Vivid Pioneer received FDA 510(k) clearance on 2025-07-10, under 510(k) number K251169.

Who is the listed applicant for Vivid Pioneer?

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 Vivid Pioneer?

The FDA product code for Vivid Pioneer is IYN.

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Outros registros que listam GE Medical Systems Ultrasound and Primary Care Diagnostics como candidato(a)

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 os 65 dispositivos →

Dispositivos Relacionados (Código: IYN)

Fonte oficial

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