ImagenSPECT

GUDID 00862611000349

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.

SPECT system application software SPECT system application software SPECT system application software SPECT system application software SPECT system application software SPECT system application software SPECT system application software SPECT system application software SPECT system application software SPECT system application software SPECT system application software SPECT system application software SPECT system application software SPECT system application software SPECT system application software SPECT system application software SPECT system application software SPECT system application software SPECT system application software
Primary Device ID00862611000349
NIH Device Record Key82ad6028-d6fb-4be8-a301-eee73661a42d
Commercial Distribution StatusIn Commercial Distribution
Brand NameImagenSPECT
Version Model Number3.0
Company DUNS626962596
Company NameCARDIOVASCULAR IMAGING TECHNOLOGIES L.L.C.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8165312842
Emailscourter@cvit.com
Phone8165312842
Emailscourter@cvit.com
Phone8165312842
Emailscourter@cvit.com
Phone8165312842
Emailscourter@cvit.com
Phone8165312842
Emailscourter@cvit.com
Phone8165312842
Emailscourter@cvit.com
Phone8165312842
Emailscourter@cvit.com
Phone8165312842
Emailscourter@cvit.com
Phone8165312842
Emailscourter@cvit.com
Phone8165312842
Emailscourter@cvit.com
Phone8165312842
Emailscourter@cvit.com
Phone8165312842
Emailscourter@cvit.com
Phone8165312842
Emailscourter@cvit.com
Phone8165312842
Emailscourter@cvit.com
Phone8165312842
Emailscourter@cvit.com
Phone8165312842
Emailscourter@cvit.com
Phone8165312842
Emailscourter@cvit.com
Phone8165312842
Emailscourter@cvit.com
Phone8165312842
Emailscourter@cvit.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100862611000349 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KPSSystem, Tomography, Computed, Emission

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-10
Device Publish Date2020-11-02

On-Brand Devices [ImagenSPECT]

00862611000301The ImagenSPECT™ system is a software application that provides a processing environment for t
00862611000349ImagenSPECT™ 3.0 is a Windows application which allows physicians and healthcare professionals

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