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#

ImagenSPECT

2016-01-25

CARDIOVASCULAR IMAGING TECHNOLOGIES

IMAGEN3D

2012-10-24

CARDIOVASCULAR IMAGING TECHNOLOGIES

IMAGENPRO

2005-03-17

CARDIOVASCULAR IMAGING TECHNOLOGIES, LLC

IMAGENMD

2004-07-22

CARDIOVASCULAR IMAGING TECHNOLOGIES, LLC

GUDID#

ImagenSPECT - ImagenSPECT™ 3.0 is a Windows application which allows physicians and healthcare professionals to inspect, reconstruct and reorient myocardial perfusion SPECT images. The system processes gated and ungated SPECT cardiac images to create 3D tomographic data. The user can correct for patient motion, change filter settings, change reconstruction settings, range of reconstruction, and reorientation angles. The application also models the influence of distance dependent blur. The use of this system is limited to qualified, licensed healthcare providers (radiologists, nuclear cardiologists or nuclear medicine physicians) trained in the use of nuclear medicine imaging devices. This software also processes, display and performs quantitative calculations of LVEF on multigated acquisition blood pool scans (MUGA). ImagenSPECT™ 3.0 is used to quantitate the uptake of 99mTc pyrophosphate in early and late planar and SPECT studies.The ImagenSPECT™ 3.0 system is designed to take nuclear medicine data from commercially available SPECT systems and process the data into a format that can be visualized by a separate computer program or workstation. In addition, quarter-counts, half dose and/or half-time scans can be reconstructed with ImagenSPECT™ 3.0 using resolution recovery, iterative reconstruction and is equivalent to the predicate ImagenSPECT™ (k152503) using half-counts and full counts (full-time scan, half dose/ half-time, full dose).

CARDIOVASCULAR IMAGING TECHNOLOGIES L.L.C.

2020-11-02