NM/CT 850, NM/CT 860

System, Tomography, Computed, Emission

GE Healthcare

The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Nm/ct 850, Nm/ct 860.

Pre-market Notification Details

Device IDK173816
510k NumberK173816
Device Name:NM/CT 850, NM/CT 860
ClassificationSystem, Tomography, Computed, Emission
Applicant GE Healthcare 4 Hayozma Street Tirat Hacarmel,  IL 30200
ContactGeorge Mashour
CorrespondentGeorge Mashour
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 Received2017-12-15
Decision Date2018-04-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840682145497 K173816 000
00840682145473 K173816 000
00840682145442 K173816 000
00840682145930 K173816 000
00840682145527 K173816 000
00840682145510 K173816 000
00840682145480 K173816 000
00840682140775 K173816 000
00840682140751 K173816 000

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