| Primary Device ID | 15420045510760 |
| NIH Device Record Key | 1962150b-5fd3-478e-83c7-252a1bdad8da |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Selenia Dimensions |
| Version Model Number | SDM-SYS-6000-3D |
| Catalog Number | SDM-SYS-6000-3D |
| Company DUNS | 139534114 |
| 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 | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15420045510760 [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 | 2024-07-08 |
| Device Publish Date | 2024-06-28 |
| 15420045507500 | ASY-10775 |
| 15420045507203 | ASY-05469 |
| 15420045507166 | ASY-02275 |
| 15420045507159 | ASY-02165 |
| 15420045507142 | ASY-02164 |
| 15420045507135 | ASY-02163 |
| 15420045507128 | ASY-02162 |
| 15420045507111 | ASY-02037 |
| 15420045507104 | ASY-02036 |
| 15420045507098 | ASY-02028 |
| 15420045507081 | ASY-01994 |
| 15420045507074 | ASY-01993 |
| 15420045507067 | ASY-01986 |
| 15420045507050 | ASY-01985 |
| 15420045507043 | ASY-01950 |
| 15420045507036 | ASY-01946 |
| 15420045507029 | ASY-01945 |
| 15420045507012 | ASY-01940 |
| 15420045506930 | ASY-08499 |
| 15420045506923 | ASY-08500 |
| 15420045505674 | ASY-03342 |
| 15420045505650 | PRD-01702 |
| 15420045505643 | PRD-01702 |
| 15420045505636 | ASY-04160 |
| 15420045505629 | ASY-08483 |
| 15420045505612 | ASY-08482 |
| 15420045505605 | ASY-07460 |
| 15420045505599 | ASY-03339 |
| 15420045505582 | ASY-01966 |
| 15420045505575 | ASY-06202 |
| 15420045505568 | ASY-03694 |
| 25420045512341 | ASY-11738 |
| 25420045512334 | ASY-11739 |
| 15420045512344 | ASY-11738 |
| 15420045512337 | ASY-11739 |
| 25420045512358 | ASY-13532 |
| 15420045512351 | ASY-13532 |
| 15420045514713 | ASY-04160 |
| 15420045514706 | RM-ASY-04160 |
| 15420045510760 | Selenia® Dimensions® digital mammography system is a mammographic system used for capturing d |
| 15420045510784 | Selenia® Dimensions® digital mammography system is a mammographic system used for capturing d |
| 15420045510777 | Selenia® Dimensions® digital mammography system is a mammographic system used for capturing d |
| 15420045510753 | Selenia® Dimensions® digital mammography system is a mammographic system used for capturing d |
| 15420045510616 | Selenia® Dimensions® digital mammography system is a mammographic system used for capturing d |