Discovery MI Gen2

System, Tomography, Computed, Emission

GE Medical Systems, LLC.

The following data is part of a premarket notification filed by Ge Medical Systems, Llc. with the FDA for Discovery Mi Gen2.

Pre-market Notification Details

Device IDK211846
510k NumberK211846
Device Name:Discovery MI Gen2
ClassificationSystem, Tomography, Computed, Emission
Applicant GE Medical Systems, LLC. 3000 North Grandview Blvd Waukesha,  WI  53188
ContactLaura Turner
CorrespondentLaura Turner
GE Medical Systems, LLC. 3000 North Grandview Blvd Waukesha,  WI  53188
Product CodeKPS  
CFR Regulation Number892.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-15
Decision Date2021-08-20

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