| Primary Device ID | 09421904268074 |
| NIH Device Record Key | 94709ede-402a-4a80-b39d-906690b7f501 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VolparaServer |
| Version Model Number | 1.3 |
| Company DUNS | 590762212 |
| Company Name | VOLPARA HEALTH TECHNOLOGIES LIMITED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09421904268074 [Primary] |
| LMD | System, Digital Image Communications, Radiological |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-10-07 |
| Device Publish Date | 2016-04-22 |
| 09421904268333 - Volpara Scorecard | 2025-05-14 |
| 09421904268340 - Volpara Live | 2025-05-14 |
| 09421904268241 - VolparaDensity | 2020-10-09 |
| 09421904268265 - VolparaDoseRT | 2020-10-02 VolparaDoseRT 3.4.2 |
| 09421904268272 - VolparaDoseSR | 2020-10-02 VolparaDoseSR 3.4.2 |
| 09421904268289 - Volpara Density Map | 2020-10-02 Volpara Density Map 3.4.2 |
| 09421904268296 - VolparaDoseRT | 2020-10-02 VolparaDoseRT 4.0 |
| 09421904268302 - VolparaDoseSR | 2020-10-02 VolparaDoseSR 4.0 |