FDA 510(k)

LOGIQ Totus

Número K: K253370 · 2026-01-08

RequerenteGE Medical Systems Ultrasound and Primary Care Diagnostics

Data da decisão2026-01-08

Código do produtoIYN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

LOGIQ Totus 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 2026-01-08 under 510(k) number K253370. 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 LOGIQ Totus?

LOGIQ Totus is a medical device that received FDA 510(k) clearance on 2026-01-08. The listed applicant is GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K253370.

When did LOGIQ Totus receive FDA 510(k) clearance?

LOGIQ Totus received FDA 510(k) clearance on 2026-01-08, under 510(k) number K253370.

Who is the listed applicant for LOGIQ Totus?

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 LOGIQ Totus?

The FDA product code for LOGIQ Totus 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 K253366LOGIQ Fortis

Ver todos os 65 dispositivos →

Dispositivos Relacionados (Código: IYN)

Fonte oficial

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