ImagenUniversal

GUDID 00862611000332

ImagenUniversal is a Windows application that allows physicians and healthcare professionals to correct myocardial perfusion PET images for transmission and emission misregistration, prompt gamma events, photon scatter and image noise.

CARDIOVASCULAR IMAGING TECHNOLOGIES L.L.C.

Radiology DICOM image processing application software
Primary Device ID00862611000332
NIH Device Record Key4173b7c5-5c10-48ee-8f1a-fadce92b2292
Commercial Distribution StatusIn Commercial Distribution
Brand NameImagenUniversal
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
GS100862611000332 [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 Date2018-01-31

Devices Manufactured by CARDIOVASCULAR IMAGING TECHNOLOGIES L.L.C.

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00862611000325 - ImagenQ2019-10-07 The ImagenMD with ImagenQ system is software that allows the user to visualize raw PET and/or PET/CT data, assist in evaluating
00862611000332 - ImagenUniversal2019-10-07ImagenUniversal is a Windows application that allows physicians and healthcare professionals to correct myocardial perfusion PET images for transmission and emission misregistration, prompt gamma events, photon scatter and image noise.
00862611000332 - ImagenUniversal2019-10-07 ImagenUniversal is a Windows application that allows physicians and healthcare professionals to correct myocardial perfusion PET
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