ImagenSPECT

GUDID 00862611000349

ImagenSPECT™ 3.0 is a Windows application which allows physicians and healthcare professionals to inspect, reconstruct and reorient myocardial perfusion SPECT images. The system processes gated and ungated SPECT cardiac images to create 3D tomographic data. The user can correct for patient motion, change filter settings, change reconstruction settings, range of reconstruction, and reorientation angles. The application also models the influence of distance dependent blur. The use of this system is limited to qualified, licensed healthcare providers (radiologists, nuclear cardiologists or nuclear medicine physicians) trained in the use of nuclear medicine imaging devices. This software also processes, display and performs quantitative calculations of LVEF on multigated acquisition blood pool scans (MUGA). ImagenSPECT™ 3.0 is used to quantitate the uptake of 99mTc pyrophosphate in early and late planar and SPECT studies. The ImagenSPECT™ 3.0 system is designed to take nuclear medicine data from commercially available SPECT systems and process the data into a format that can be visualized by a separate computer program or workstation. In addition, quarter-counts, half dose and/or half-time scans can be reconstructed with ImagenSPECT™ 3.0 using resolution recovery, iterative reconstruction and is equivalent to the predicate ImagenSPECT™ (k152503) using half-counts and full counts (full-time scan, half dose/ half-time, full dose).

CARDIOVASCULAR IMAGING TECHNOLOGIES L.L.C.

SPECT system application software

• Primary Device ID: 00862611000349
• NIH Device Record Key: 82ad6028-d6fb-4be8-a301-eee73661a42d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ImagenSPECT
• Version Model Number: 3.0
• 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: false
• 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: 8165312842
• Email: scourter@cvit.com
• Phone: 8165312842
• Email: scourter@cvit.com
• Phone: 8165312842
• Email: scourter@cvit.com
• Phone: 8165312842
• Email: scourter@cvit.com
• Phone: 8165312842
• Email: scourter@cvit.com
• Phone: 8165312842
• Email: scourter@cvit.com
• Phone: 8165312842
• Email: scourter@cvit.com
• Phone: 8165312842
• Email: scourter@cvit.com
• Phone: 8165312842
• Email: scourter@cvit.com
• Phone: 8165312842
• Email: scourter@cvit.com
• Phone: 8165312842
• Email: scourter@cvit.com
• Phone: 8165312842
• Email: scourter@cvit.com
• Phone: 8165312842
• Email: scourter@cvit.com
• Phone: 8165312842
• Email: scourter@cvit.com
• Phone: 8165312842
• Email: scourter@cvit.com
• Phone: 8165312842
• Email: scourter@cvit.com
• Phone: 8165312842
• Email: scourter@cvit.com
• Phone: 8165312842
• Email: scourter@cvit.com
• Phone: 8165312842
• Email: scourter@cvit.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00862611000349 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152503

FDA Product Code

• KPS: System, Tomography, Computed, Emission

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: 2020-11-10
• Device Publish Date: 2020-11-02

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