Selenia Dimensions 3D System

GUDID 15420045500013

Hologic, Inc.

Stationary mammographic x-ray system, digital

• Primary Device ID: 15420045500013
• NIH Device Record Key: f4470812-4894-4bef-9d8d-9aaaad9bce7d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Selenia Dimensions 3D System
• Version Model Number: 3D software
• Company DUNS: 139534114
• Company Name: Hologic, Inc.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045500013 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-09-05

Devices Manufactured by Hologic, Inc.

• 15420045517097 - DIGITAL DIAGNOSTICS SYSTEM: 2025-07-25 Computer to operate the Genius™ Review Station.
• 15420045517851 - Selenia® Dimensions®: 2025-07-25 The Selenia® Dimensions® digital mammography system generates digital mammographic images that can be used for screening and
• 15420045517882 - Selenia® Dimensions®: 2025-07-25 The Selenia® Dimensions® digital mammography system generates digital mammographic images that can be used for screening and
• 15420045517899 - Selenia® Dimensions®: 2025-07-25 The Selenia® Dimensions® digital mammography system generates digital mammographic images that can be used for screening and
• 15420045517905 - Selenia® Dimensions®: 2025-07-25 The Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the b
• 15420045517912 - Selenia® Dimensions®: 2025-07-25 The Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the b
• 15420045517929 - Selenia® Dimensions®: 2025-07-25 The Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the b
• 15420045517936 - Selenia® Dimensions®: 2025-07-25 The Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the b