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 |
15420045517097 - DIGITAL DIAGNOSTICS SYSTEM | 2025-07-25 Computer to operate the Genius™ Review Station. |
15420045517851 - Selenia® Dimensions® | 2025-07-25 The Selenia® Dimensions® digital mammography system generates digital mammographic images that can be used for screening and |
15420045517882 - Selenia® Dimensions® | 2025-07-25 The Selenia® Dimensions® digital mammography system generates digital mammographic images that can be used for screening and |
15420045517899 - Selenia® Dimensions® | 2025-07-25 The Selenia® Dimensions® digital mammography system generates digital mammographic images that can be used for screening and |
15420045517905 - Selenia® Dimensions® | 2025-07-25 The Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the b |
15420045517912 - Selenia® Dimensions® | 2025-07-25 The Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the b |
15420045517929 - Selenia® Dimensions® | 2025-07-25 The Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the b |
15420045517936 - Selenia® Dimensions® | 2025-07-25 The Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the b |