| Primary Device ID | 05400874001205 | 
| NIH Device Record Key | 689c17b6-8e2c-44b3-9cdf-3a77c24eb36c | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | IMPAX Clinical Applications | 
| Version Model Number | 4 | 
| Company DUNS | 282853795 | 
| Company Name | Agfa HealthCare NV | 
| 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 | true | 
| OTC Over-The-Counter | false | 
| Phone | 1-866-599-3868 | 
| salesinfo@agfa.com | |
| Phone | 1-866-599-3868 | 
| salesinfo@agfa.com | |
| Phone | 1-866-599-3868 | 
| salesinfo@agfa.com | |
| Phone | 1-866-599-3868 | 
| salesinfo@agfa.com | |
| Phone | 1-866-599-3868 | 
| salesinfo@agfa.com | |
| Phone | 1-866-599-3868 | 
| salesinfo@agfa.com | |
| Phone | 1-866-599-3868 | 
| salesinfo@agfa.com | |
| Phone | 1-866-599-3868 | 
| salesinfo@agfa.com | |
| Phone | 1-866-599-3868 | 
| salesinfo@agfa.com | |
| Phone | 1-866-599-3868 | 
| salesinfo@agfa.com | |
| Phone | 1-866-599-3868 | 
| salesinfo@agfa.com | |
| Phone | 1-866-599-3868 | 
| salesinfo@agfa.com | |
| Phone | 1-866-599-3868 | 
| salesinfo@agfa.com | |
| Phone | 1-866-599-3868 | 
| salesinfo@agfa.com | |
| Phone | 1-866-599-3868 | 
| salesinfo@agfa.com | |
| Phone | 1-866-599-3868 | 
| salesinfo@agfa.com | |
| Phone | 1-866-599-3868 | 
| salesinfo@agfa.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 05400874001205 [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 | 2 | 
| Public Version Date | 2023-10-18 | 
| Device Publish Date | 2019-07-22 | 
| 05400874001205 - IMPAX Clinical Applications | 2023-10-18IMPAX Volume Viewing and IMPAX PET & SPECT Viewing | 
| 05400874001205 - IMPAX Clinical Applications | 2023-10-18 IMPAX Volume Viewing and IMPAX PET & SPECT Viewing | 
| 05414904216552 - IMPAX | 2019-11-25 IMPAX SW CLIENT V6.7 | 
| 05414904218525 - Enterprise Imaging Desktops | 2019-07-23 ENT IMG SW 8. | 
| 05414904218532 - Enterprise Imaging Xero Viewer | 2019-07-23 ENT IMG SW XERO VIEWER 8.1 | 
| 05414904242902 - Enterprise Imaging Desktops | 2019-07-23 | 
| 05414904242919 - Enterprise Imaging XERO Viewer | 2019-07-23 | 
| 05414904252437 - Enterprise Imaging Desktops | 2019-07-23 | 
| 05414904252444 - Enterprise Imaging XERO Viewer | 2019-07-23 |