ImagenSPECT

GUDID 00862611000301

The ImagenSPECT™ system is a software application that provides a processing environment for the analysis and display of cardiac SPECT images. The results of this processing may be used in determining the presence of cardiac diseases. Data for ImagenSPECT is derived from a nuclear medicine gamma camera. The resulting datasets may be either planar or 3D tomograms of patient anatomy.

CARDIOVASCULAR IMAGING TECHNOLOGIES L.L.C.

SPECT system application software

• Primary Device ID: 00862611000301
• NIH Device Record Key: 7d57ac9a-4d33-42da-ba8a-af52d629d5e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ImagenSPECT
• 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	00862611000301 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152503

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: 2016-10-25

On-Brand Devices [ImagenSPECT]

• 00862611000301: The ImagenSPECT™ system is a software application that provides a processing environment for t
• 00862611000349: ImagenSPECT™ 3.0 is a Windows application which allows physicians and healthcare professionals