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

• Primary Device ID: 00862611000318
• NIH Device Record Key: ffe3ab4c-d0c0-4548-bc26-b5e6bb678b69
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ImagenPRO
• Version Model Number: 2.2
• Company DUNS: 626962596
• Company Name: CARDIOVASCULAR IMAGING TECHNOLOGIES L.L.C.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 816-531-2842
• Email: scourter@cvit.com
• Phone: 816-531-2842
• Email: scourter@cvit.com
• Phone: 816-531-2842
• Email: scourter@cvit.com
• Phone: 816-531-2842
• Email: scourter@cvit.com
• Phone: 816-531-2842
• Email: scourter@cvit.com
• Phone: 816-531-2842
• Email: scourter@cvit.com
• Phone: 816-531-2842
• Email: scourter@cvit.com
• Phone: 816-531-2842
• Email: scourter@cvit.com
• Phone: 816-531-2842
• Email: scourter@cvit.com
• Phone: 816-531-2842
• Email: scourter@cvit.com
• Phone: 816-531-2842
• Email: scourter@cvit.com
• Phone: 816-531-2842
• Email: scourter@cvit.com
• Phone: 816-531-2842
• Email: scourter@cvit.com
• Phone: 816-531-2842
• Email: scourter@cvit.com
• Phone: 816-531-2842
• Email: scourter@cvit.com
• Phone: 816-531-2842
• Email: scourter@cvit.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00862611000318 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050366

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-10-07
• Device Publish Date: 2018-01-29

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

• 00862611000349 - ImagenSPECT: 2020-11-10 ImagenSPECT™ 3.0 is a Windows application which allows physicians and healthcare professionals to inspect, reconstruct and reo
• 00862611000301 - ImagenSPECT: 2019-10-07 The ImagenSPECT™ system is a software application that provides a processing environment for the analysis and display of cardi
• 00862611000318 - ImagenPRO: 2019-10-07ImagenPRO 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 - ImagenPRO: 2019-10-07 ImagenPRO is a software application installed on desktop computers with allows physicians and healthcare professionals to inspec
• 00862611000325 - ImagenQ: 2019-10-07 The ImagenMD with ImagenQ system is software that allows the user to visualize raw PET and/or PET/CT data, assist in evaluating
• 00862611000332 - ImagenUniversal: 2019-10-07 ImagenUniversal is a Windows application that allows physicians and healthcare professionals to correct myocardial perfusion PET