Critical Care Suite

Radiological Computer-assisted Prioritization Software For Lesions

GE Medical Systems, LLC.

The following data is part of a premarket notification filed by Ge Medical Systems, Llc. with the FDA for Critical Care Suite.

Pre-market Notification Details

Device IDK183182
510k NumberK183182
Device Name:Critical Care Suite
ClassificationRadiological Computer-assisted Prioritization Software For Lesions
Applicant GE Medical Systems, LLC. 3000 N. Grandview Blvd Waukesha,  WI  53188
ContactCamille Vidal
CorrespondentCamille Vidal
GE Medical Systems, LLC. 3000 N. Grandview Blvd Waukesha,  WI  53188
Product CodeQFM  
CFR Regulation Number892.2080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-11-19
Decision Date2019-08-12

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840682146340 K183182 000
00840682147231 K183182 000
00195278217981 K183182 000

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