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 ID: 00862611000332
• NIH Device Record Key: 4173b7c5-5c10-48ee-8f1a-fadce92b2292
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ImagenUniversal
• Version Model Number: 2.0
• 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	00862611000332 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173547

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: 2018-01-31

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

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• 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: 2019-10-07ImagenUniversal 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 - ImagenUniversal: 2019-10-07 ImagenUniversal is a Windows application that allows physicians and healthcare professionals to correct myocardial perfusion PET