Selenia® Dimensions® ASY-04160-BR-V1.10

GUDID 15420045517912

The 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: 15420045517912
• NIH Device Record Key: fc43567e-af5c-42a5-bd6a-7bd9ff922c38
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Selenia® Dimensions®
• Version Model Number: ASY-04160-BR-V1.10
• Catalog Number: ASY-04160-BR-V1.10
• 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: false
• 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	15420045517912 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P010025

FDA Product Code

• MUE: Full field digital, system, x-ray, mammographic

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 [Selenia® Dimensions®]

• 15420045517646: Hologic Selenia Dimensions 6000 package for 2D screening and diagnostic mammography. Upgradable
• 15420045517639: Hologic Selenia Dimensions Avia 3000 package for 2D screening mammography or optional 2D diagnos
• 15420045517998: Selenia® Dimensions® digital mammography system generates digital mammographic images that ca
• 15420045517981: Selenia® Dimensions® digital mammography system generates digital mammographic images that ca
• 15420045517974: Selenia® Dimensions® digital mammography system generates digital mammographic images that ca
• 15420045517967: The Selenia® Dimensions® digital mammography system is a mammographic system used for capturi
• 15420045517950: The Selenia® Dimensions® digital mammography system is a mammographic system used for capturi
• 15420045517943: The Selenia® Dimensions® digital mammography system is a mammographic system used for capturi
• 15420045517936: The Selenia® Dimensions® digital mammography system is a mammographic system used for capturi
• 15420045517929: The Selenia® Dimensions® digital mammography system is a mammographic system used for capturi
• 15420045517912: The Selenia® Dimensions® digital mammography system is a mammographic system used for capturi
• 15420045517905: The Selenia® Dimensions® digital mammography system is a mammographic system used for capturi
• 15420045517899: The Selenia® Dimensions® digital mammography system generates digital mammographic images tha
• 15420045517882: The Selenia® Dimensions® digital mammography system generates digital mammographic images tha
• 15420045517851: The Selenia® Dimensions® digital mammography system generates digital mammographic images tha