| Primary Device ID | 15420045512474 |
| NIH Device Record Key | 9e9aa535-f885-4da8-b35b-5d205d952ffb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GENIUS AI DETECTION |
| Version Model Number | GENIUS AI DETECTION SOFTWARE |
| Company DUNS | 139534114 |
| Company Name | Hologic, Inc. |
| 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 | 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 | 15420045512474 [Primary] |
| OTE | Digital breast tomosynthesis |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-12-09 |
| Device Publish Date | 2020-12-01 |
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