Primary Device ID | 09421904268340 |
NIH Device Record Key | 349b364b-4087-473a-91a3-5efc7d6df651 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Volpara Live |
Version Model Number | 2.4 |
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 | 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 | 09421904268340 [Primary] |
LHO | Instrument, Quality-Assurance, Radiologic |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-05-14 |
Device Publish Date | 2025-05-06 |
09421904268333 - Volpara Scorecard | 2025-05-14 |
09421904268340 - Volpara Live | 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 |