| 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 |
| 15420045517394 - Hologic | 2025-09-05 NG Res Primers Analyte Specific Reagent. |
| 15420045517400 - Hologic | 2025-09-05 NG Res Probe (FAM) Analyte Specific Reagent. |
| 15420045517417 - Hologic | 2025-09-05 NG Res C272T IVT Control (Positive Control). |
| 15420045517424 - Hologic | 2025-09-05 NG IVT Wild Type Control (Negative Control). |
| 15420045512412 - DEFINITY CERVICAL DILATOR, 5MM | 2025-07-29 |
| 15420045512429 - DEFINITY CERVICAL DILATOR, 7MM | 2025-07-29 |
| 15420045512436 - DEFINITY CERVICAL DILATOR, 9MM | 2025-07-29 |
| 15420045517097 - DIGITAL DIAGNOSTICS SYSTEM | 2025-07-25 Computer to operate the Genius™ Review Station. |