| 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 |