3Dimensions™ ASY-11748-2D-V20
GUDID 15420045518049
Selenia® Dimensions® Acquisition Workstation (AWS) is the primary user interface for the Selenia® Dimensions® digital mammography system.
Hologic, Inc.
Stationary mammographic x-ray system, digital| Primary Device ID | 15420045518049 |
| NIH Device Record Key | 3ea9c54e-f4bd-40e2-a20a-32735dd779ed |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 3Dimensions™ |
| Version Model Number | ASY-11748-2D-V20 |
| Catalog Number | ASY-11748-2D-V20 |
| Company DUNS | 964430230 |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| 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 |
Operating and Storage Conditions
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15420045518049 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P080003
FDA Product Code
| OTE | Digital breast tomosynthesis |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-07-25 |
| Device Publish Date | 2025-07-17 |
On-Brand Devices [3Dimensions™]
| 15420045518094 | Selenia® Dimensions® digital mammography system is a mammographic system used for capturing d |
| 15420045518070 | Selenia® Dimensions® digital mammography system is a mammographic system used for capturing d |
| 15420045518063 | Selenia® Dimensions® digital mammography system is a mammographic system used for capturing d |
| 15420045518056 | Selenia® Dimensions® digital mammography system is a mammographic system used for capturing d |
| 15420045518049 | Selenia® Dimensions® Acquisition Workstation (AWS) is the primary user interface for the Sele |
| 15420045518032 | Selenia® Dimensions® Acquisition Workstation (AWS) is the primary user interface for the Sele |
| 15420045518025 | Selenia® Dimensions® digital mammography system is a mammographic system used for capturing d |
| 15420045518018 | Selenia® Dimensions® digital mammography system is a mammographic system used for capturing d |
| 15420045518001 | Selenia® Dimensions® digital mammography system is a mammographic system used for capturing d |
Trademark Results [3Dimensions]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 3DIMENSIONS 87243930 5771595 Live/Registered |
Hologic, Inc. 2016-11-21 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.