ImagenSPECT

GUDID 00862611000301

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.

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
Primary Device ID00862611000301
NIH Device Record Key7d57ac9a-4d33-42da-ba8a-af52d629d5e6
Commercial Distribution StatusIn Commercial Distribution
Brand NameImagenSPECT
Version Model Number2.0
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone816-531-2842
Emailscourter@cvit.com
Phone816-531-2842
Emailscourter@cvit.com
Phone816-531-2842
Emailscourter@cvit.com
Phone816-531-2842
Emailscourter@cvit.com
Phone816-531-2842
Emailscourter@cvit.com
Phone816-531-2842
Emailscourter@cvit.com
Phone816-531-2842
Emailscourter@cvit.com
Phone816-531-2842
Emailscourter@cvit.com
Phone816-531-2842
Emailscourter@cvit.com
Phone816-531-2842
Emailscourter@cvit.com
Phone816-531-2842
Emailscourter@cvit.com
Phone816-531-2842
Emailscourter@cvit.com
Phone816-531-2842
Emailscourter@cvit.com
Phone816-531-2842
Emailscourter@cvit.com
Phone816-531-2842
Emailscourter@cvit.com
Phone816-531-2842
Emailscourter@cvit.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100862611000301 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-10-07
Device Publish Date2016-10-25

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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