3Dimensions™ ASY-10559-CN

GUDID 15420045518001

Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breast.

Hologic, Inc.

Stationary mammographic x-ray system, digital

• Primary Device ID: 15420045518001
• NIH Device Record Key: ed864e09-cffc-422f-b81a-2c1a90178d41
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3Dimensions™
• Version Model Number: ASY-10559-CN
• Catalog Number: ASY-10559-CN
• 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
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045518001 [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