SnapShot Freeze 2

System, X-ray, Tomography, Computed

GE Medical Systems, LLC.

The following data is part of a premarket notification filed by Ge Medical Systems, Llc. with the FDA for Snapshot Freeze 2.

Pre-market Notification Details

Device IDK183161
510k NumberK183161
Device Name:SnapShot Freeze 2
ClassificationSystem, X-ray, Tomography, Computed
Applicant GE Medical Systems, LLC. 3000 N. Grandview Blvd Waukesha,  WI  53188
ContactLaura Turner
CorrespondentLaura Turner
GE Medical Systems, LLC. 3000 N. Grandview Blvd Waukesha,  WI  53188
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-11-15
Decision Date2019-02-13
Summary:summary

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