ImagenQ

GUDID 00862611000356

The ImagenMD with ImagenQ system is software that allows the user to visualize raw PET and/or PET/CT data, assist in evaluating the quality of PET scans, and perform quantitative measurements of tracer uptake to aid in the interpretation of myocardial perfusion PET images.

CARDIOVASCULAR IMAGING TECHNOLOGIES L.L.C.

Radiology DICOM image processing application software

• Primary Device ID: 00862611000356
• NIH Device Record Key: b3430c5f-3abd-46a1-bafd-0347bd9fdf1b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ImagenQ
• Version Model Number: 2.1
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00862611000356 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080770

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-17
• Device Publish Date: 2025-01-09

On-Brand Devices [ImagenQ]

• 00862611000325: The ImagenMD with ImagenQ system is software that allows the user to visualize raw PET and/or PE
• 00862611000356: The ImagenMD with ImagenQ system is software that allows the user to visualize raw PET and/or PE