SIGNA PET/MR

Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance

GE Medical Systems, LLC

The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for Signa Pet/mr.

Pre-market Notification Details

Device IDK213709
510k NumberK213709
Device Name:SIGNA PET/MR
ClassificationTomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
Applicant GE Medical Systems, LLC 3200 N Grandview Blvd Waukesha,  WI  53188
ContactBrian R Zielski
CorrespondentBrian R Zielski
GE Medical Systems, LLC 3200 N Grandview Blvd Waukesha,  WI  53188
Product CodeOUO  
CFR Regulation Number892.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-11-24
Decision Date2022-01-20

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00195278648877 K213709 000
00195278729224 K213709 000

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