Omni Legend

System, Tomography, Computed, Emission

GE Healthcare

The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Omni Legend.

Pre-market Notification Details

Device IDK221932
510k NumberK221932
Device Name:Omni Legend
ClassificationSystem, Tomography, Computed, Emission
Applicant GE Healthcare 4 Hayozma Street Tirat Hacarmel,  IL 30200
ContactAlexandra Lifshits
CorrespondentAlexandra Lifshits
GE Healthcare 4 Hayozma Street Tirat Hacarmel,  IL 30200
Product CodeKPS  
CFR Regulation Number892.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-07-01
Decision Date2022-09-02

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00195278592309 K221932 000

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