FDA.reportPublic FDA data

CARDIOVASCULAR IMAGING TECHNOLOGIES, LLC

Matched from indexed company URL: Cardiovascular Imaging Technologies

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30045049203004504920CARDIOVASCULAR IMAGING TECHNOLOGIES, LLC1N2026-01-014320 Wornall Rd Ste 114 KANSAS CITY MO US 64111

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00862611000301ImagenSPECT - The ImagenSPECT™ system is a software application that provides a processing environment for the analysis and display of cardiac SPECT images. The results of this processing may be used in determining the presence of cardiac diseases. Data for ImagenSPECT is derived from a nuclear medicine gamma camera. The resulting datasets may be either planar or 3D tomograms of patient anatomy.816-531-2842scourter@cvit.com
00862611000318ImagenPRO - ImagenPRO is a software application installed on desktop computers with allows physicians and healthcare professionals to inspect, reconstruct, and reorient myocardial perfusion PET images. The system processes perfusion and gated PET raw emission and transmission data to create 3D tomographic data. The user can select correction parameters, filter setting, range of reconstruction, and reorientation angels.816-531-2842scourter@cvit.com
00862611000325ImagenQ - The ImagenMD with ImagenQ system is software that allows the user to visualize raw PET and/or PET/CT data, assist in evaluating the quality of PET scans, and perform quantitative measurements of tracer uptake to aid in the interpretation of myocardial perfusion PET images.816-531-2842scourter@cvit.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
627242016730761K201933ImagenSPECT 3.0KPS2020-08-11
627241679358809K173547ImagenUniversalKPS2018-01-12
627241851480383K152503ImagenSPECTKPS2016-01-25
627241763878754K122241IMAGEN3DKPS2012-10-24
627241626594375K080770IMAGENMD WITH IMAGENQLLZ2008-04-09
627241886169697K050366IMAGENPROKPS2005-03-17
627241186462010K041671IMAGENMDKPS2004-07-22

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KPS62020-08-11
LLZ12008-04-09

PMN#

GUDID#