3Dimensions
GUDID 15420045510388
Hologic, Inc.
Stationary mammographic x-ray system, digital| Primary Device ID | 15420045510388 |
| NIH Device Record Key | f9cb6dc5-beeb-4a7c-9a17-05e3f235f246 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 3Dimensions |
| Version Model Number | ASY-11748-2D |
| Company DUNS | 139534114 |
| 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 | false |
| 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 | |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 | 15420045510388 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
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 | 2019-11-13 |
| Device Publish Date | 2019-11-05 |
On-Brand Devices [3Dimensions]
| 15420045508033 | ASY-10636-3D |
| 15420045508026 | ASY-10636-2D |
| 15420045508019 | ASY-10559 |
| 15420045507296 | 3DIMENSIONS SOFTWARE |
| 15420045507289 | INTELLIGENT 2D SOFTWARE |
| 15420045507272 | CLARITY HD SOFTWARE |
| 15420045510395 | ASY-11748-3D |
| 15420045511897 | ASY-11748-CHD |
| 15420045510388 | ASY-11748-2D |
| 15420045510593 | Selenia® Dimensions® Mobile digital mammography system is a mobile mammographic system used f |
| 15420045510586 | Selenia® Dimensions® digital mammography system is a mammographic system used for capturing d |
| 15420045510579 | Selenia® Dimensions® digital mammography system is a mammographic system used for capturing d |
| 15420045510562 | Selenia® Dimensions® Mobile digital mammography system is a mobile mammographic system used f |
| 15420045510555 | Selenia® Dimensions® digital mammography system is a mammographic system used for capturing d |
| 15420045510548 | Selenia® Dimensions® digital mammography system is a mammographic system used for capturing d |
| 15420045510524 | 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 |
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