| Primary Device ID | 04251332930008 |
| NIH Device Record Key | 5c335224-0a3e-4bef-b07e-d912fc0215b3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Visage Breast Density |
| Version Model Number | 1.0 |
| Company DUNS | 340229090 |
| Company Name | Visage Imaging GmbH |
| 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 | true |
| Serial Number | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04251332930008 [Primary] |
| QIH | Automated Radiological Image Processing Software |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-05-10 |
| Device Publish Date | 2021-04-30 |
| 04251332910093 - Visage 7 | 2025-06-18 |
| 04251332920047 - Visage Ease Pro | 2024-03-08 |
| 04251332910055 - Visage 7 | 2023-10-18 |
| 04251332910086 - Visage 7 | 2023-06-23 |
| 04251332920030 - Visage Ease Pro | 2023-06-23 |
| 04251332910079 - Visage 7 | 2022-02-24 |
| 04251332930008 - Visage Breast Density | 2021-05-10 |
| 04251332930008 - Visage Breast Density | 2021-05-10 |
| 04251332910062 - Visage 7 | 2021-05-07 |