ImagenPRO

GUDID 00862611000318

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.

CARDIOVASCULAR IMAGING TECHNOLOGIES L.L.C.

Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software
Primary Device ID00862611000318
NIH Device Record Keyffe3ab4c-d0c0-4548-bc26-b5e6bb678b69
Commercial Distribution StatusIn Commercial Distribution
Brand NameImagenPRO
Version Model Number2.2
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
GS100862611000318 [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 Date2018-01-29

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

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00862611000301 - ImagenSPECT2019-10-07 The ImagenSPECT™ system is a software application that provides a processing environment for the analysis and display of cardi
00862611000318 - ImagenPRO2019-10-07ImagenPRO 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.
00862611000318 - ImagenPRO2019-10-07 ImagenPRO is a software application installed on desktop computers with allows physicians and healthcare professionals to inspec
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 - ImagenUniversal2019-10-07 ImagenUniversal is a Windows application that allows physicians and healthcare professionals to correct myocardial perfusion PET
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