FDA 510(k)

LOGIQ E10s

Numéro K : K251963 · 2025-10-29

DemandeurGE Medical Systems Ultrasound and Primary Care Diagnostics

Date de décision2025-10-29

Code produitIYN

Comité consultatifRA

DécisionSubstantially Equivalent

Résumé du dispositif

LOGIQ E10s 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 2025-10-29 under 510(k) number K251963. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the LOGIQ E10s?

LOGIQ E10s is a medical device that received FDA 510(k) clearance on 2025-10-29. The listed applicant is GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K251963.

When did LOGIQ E10s receive FDA 510(k) clearance?

LOGIQ E10s received FDA 510(k) clearance on 2025-10-29, under 510(k) number K251963.

Who is the listed applicant for LOGIQ E10s?

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 E10s?

The FDA product code for LOGIQ E10s is IYN.

Essais cliniques associés

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Autres dossiers indiquant GE Medical Systems Ultrasound and Primary Care Diagnostics en tant que demandeur

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

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Dispositifs connexes (Code : IYN)

Source officielle

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