| 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 |
| Phone | 816-531-2842 |
| scourter@cvit.com | |
| Phone | 816-531-2842 |
| scourter@cvit.com | |
| Phone | 816-531-2842 |
| scourter@cvit.com | |
| Phone | 816-531-2842 |
| scourter@cvit.com | |
| Phone | 816-531-2842 |
| scourter@cvit.com | |
| Phone | 816-531-2842 |
| scourter@cvit.com | |
| Phone | 816-531-2842 |
| scourter@cvit.com | |
| Phone | 816-531-2842 |
| scourter@cvit.com | |
| Phone | 816-531-2842 |
| scourter@cvit.com | |
| Phone | 816-531-2842 |
| scourter@cvit.com | |
| Phone | 816-531-2842 |
| scourter@cvit.com | |
| Phone | 816-531-2842 |
| scourter@cvit.com | |
| Phone | 816-531-2842 |
| scourter@cvit.com | |
| Phone | 816-531-2842 |
| scourter@cvit.com | |
| Phone | 816-531-2842 |
| scourter@cvit.com | |
| Phone | 816-531-2842 |
| scourter@cvit.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00862611000332 [Primary] |
| LLZ | System, Image Processing, Radiological |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-10-07 |
| Device Publish Date | 2018-01-31 |
| 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 | 2019-10-07 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 |