AFFIRM™ CONTRAST BIOPSY CMP-01771

GUDID 15420045512948

Affirm® breast biopsy guidance system software is designed to allow the accurate location of lesions in the breast in three dimensions. It is intended to provide guidance for interventional purposes such as biopsy, pre-surgerical localization or treatment devices.

Hologic, Inc.

Mammographic stereotactic biopsy system

• Primary Device ID: 15420045512948
• NIH Device Record Key: cdff0717-26ac-4df0-bb3b-44dc674a0761
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AFFIRM™ CONTRAST BIOPSY
• Version Model Number: AFFIRM™ CONTRAST BIOPSY SOFTWARE
• Catalog Number: CMP-01771
• Company DUNS: 139534114
• Company Name: Hologic, Inc.
• Device Count: 1
• DM Exempt: true
• 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: 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: 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
• 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	15420045512948 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103512

FDA Product Code

• IZH: System, x-ray, mammographic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-04-19
• Device Publish Date: 2020-11-18

Devices Manufactured by Hologic, Inc.

• 15420045510524 - 3Dimensions: 2024-09-26 Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breas
• 15420045510616 - Selenia Dimensions: 2024-09-26 Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breas
• 15420045510753 - Selenia Dimensions: 2024-09-26 Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breas
• 15420045510777 - Selenia Dimensions: 2024-09-26 Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breas
• 15420045510784 - Selenia Dimensions: 2024-09-26 Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breas
• 15420045512641 - Dimensions: 2024-09-23 Contrast Enhanced Digital Mammography Imaging Kit
• 15420045512658 - I-View: 2024-09-23
• 15420045512665 - I-View: 2024-09-23