FDA 510(k)

LOGIQ E9, LOGIQ E9 XDClear 2.0

Numéro K : K163077 · 2016-11-17

DemandeurGE Medical Systems Ultrasound and Primary Care Diagnostics

Date de décision2016-11-17

Code produitIYN

Comité consultatifRA

DécisionSubstantially Equivalent

Résumé du dispositif

LOGIQ E9, LOGIQ E9 XDClear 2.0 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 2016-11-17 under 510(k) number K163077. 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 E9, LOGIQ E9 XDClear 2.0?

LOGIQ E9, LOGIQ E9 XDClear 2.0 is a medical device that received FDA 510(k) clearance on 2016-11-17. The listed applicant is GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K163077.

When did LOGIQ E9, LOGIQ E9 XDClear 2.0 receive FDA 510(k) clearance?

LOGIQ E9, LOGIQ E9 XDClear 2.0 received FDA 510(k) clearance on 2016-11-17, under 510(k) number K163077.

Who is the listed applicant for LOGIQ E9, LOGIQ E9 XDClear 2.0?

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 E9, LOGIQ E9 XDClear 2.0?

The FDA product code for LOGIQ E9, LOGIQ E9 XDClear 2.0 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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