ImagenUniversal

System, Tomography, Computed, Emission

Cardiovascular Imaging Technologies

The following data is part of a premarket notification filed by Cardiovascular Imaging Technologies with the FDA for Imagenuniversal.

Pre-market Notification Details

Device IDK173547
510k NumberK173547
Device Name:ImagenUniversal
ClassificationSystem, Tomography, Computed, Emission
Applicant Cardiovascular Imaging Technologies 4320 Wornall Road, Suite 114 Kansas City,  UT  64111
ContactJames A. Case
CorrespondentMelanie K. Hasek
PRA Health Sciences 9755 Ridge Drive Lenexa,  KS  66219
Product CodeKPS  
CFR Regulation Number892.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-11-16
Decision Date2018-01-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00862611000332 K173547 000

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