Discovery NM/CT 670 CZT

System, Tomography, Computed, Emission

GE HEALTHCARE

The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Discovery Nm/ct 670 Czt.

Pre-market Notification Details

Device IDK153402
510k NumberK153402
Device Name:Discovery NM/CT 670 CZT
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 Received2015-11-24
Decision Date2016-01-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840682145725 K153402 000
00840682141635 K153402 000
00840682140843 K153402 000
00840682139380 K153402 000
00840682123853 K153402 000
00840682123778 K153402 000
00840682121446 K153402 000

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