IMAGEN3D

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 Imagen3d.

Pre-market Notification Details

Device IDK122241
510k NumberK122241
Device Name:IMAGEN3D
ClassificationSystem, Tomography, Computed, Emission
Applicant CARDIOVASCULAR IMAGING TECHNOLOGIES 9755 RIDGE DRIVE Lenexa,  KS  66219
ContactMelanie Hasek
CorrespondentMelanie Hasek
CARDIOVASCULAR IMAGING TECHNOLOGIES 9755 RIDGE DRIVE Lenexa,  KS  66219
Product CodeKPS  
CFR Regulation Number892.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-07-27
Decision Date2012-10-24
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.