3DQuorum

GUDID 15420045512313

Hologic, Inc.

Stationary mammographic x-ray system, digital

• Primary Device ID: 15420045512313
• NIH Device Record Key: 9091de70-7b47-420a-a6ae-22a7627a5c50
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3DQuorum
• Version Model Number: 3DQUORUM SOFTWARE
• 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: 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	15420045512313 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P080003
• 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: 2019-09-26
• Device Publish Date: 2019-09-18

Devices Manufactured by Hologic, Inc.

• 15420045517394 - Hologic: 2025-09-05 NG Res Primers Analyte Specific Reagent.
• 15420045517400 - Hologic: 2025-09-05 NG Res Probe (FAM) Analyte Specific Reagent.
• 15420045517417 - Hologic: 2025-09-05 NG Res C272T IVT Control (Positive Control).
• 15420045517424 - Hologic: 2025-09-05 NG IVT Wild Type Control (Negative Control).
• 15420045512412 - DEFINITY CERVICAL DILATOR, 5MM: 2025-07-29
• 15420045512429 - DEFINITY CERVICAL DILATOR, 7MM: 2025-07-29
• 15420045512436 - DEFINITY CERVICAL DILATOR, 9MM: 2025-07-29
• 15420045517097 - DIGITAL DIAGNOSTICS SYSTEM: 2025-07-25 Computer to operate the Genius™ Review Station.