| Primary Device ID | 15420045500037 |
| NIH Device Record Key | a2e42487-d03b-4e9a-8c55-d91443427e39 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ImageChecker CAD 10.0 |
| Version Model Number | 10.0 |
| Catalog Number | R2LIC-2111 |
| Company DUNS | 153623137 |
| Company Name | Hologic, Inc. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| 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 | 15420045500037 [Primary] |
| MYN | Analyzer,medical image |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-10-07 |
| Device Publish Date | 2014-07-01 |
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| 15420045517646 - Selenia® Dimensions® | 2025-05-26 Hologic Selenia Dimensions 6000 package for 2D screening and diagnostic mammography. Upgradable to interventional or mobile. |
| 15420045517585 - DIGITAL DIAGNOSTICS SYSTEM | 2025-04-11 Computer to operate the Genius™ Review Station. |
| 15420045516991 - Aptima® | 2025-03-24 Aptima® SARS-CoV-2 Assay, 100 test, box 1 of 2 (2°C to 8°C box). |
| 15420045517004 - Aptima® | 2025-03-24 Aptima® SARS-CoV-2 Assay, 100 test, box 2 of 2 (15°C to 30°C box). |
| 15420045517035 - Aptima® | 2025-03-24 Aptima® SARS-CoV-2 Assay Controls Kit. |
| 15420045517059 - Aptima® | 2024-12-27 Aptima® BV assay, 250 test, box 1 of 2 (2°C to 8°C box). The Aptima® BV assay is an in vitro nucleic acid amplification test |
| 15420045517066 - Aptima® | 2024-12-27 Aptima® BV assay, 250 test, box 2 of 2 (15°C to 30°C box). The Aptima® BV assay is an in vitro nucleic acid amplification te |