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

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045512313 [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: 2019-09-26
• Device Publish Date: 2019-09-18

Devices Manufactured by Hologic, Inc.

• 15420045510548 - 3Dimensions: 2024-07-08 Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breas
• 15420045510555 - 3Dimensions: 2024-07-08 Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breas
• 15420045510562 - 3Dimensions: 2024-07-08 Selenia® Dimensions® Mobile digital mammography system is a mobile mammographic system used for capturing digital x-ray image
• 15420045510579 - 3Dimensions: 2024-07-08 Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breas
• 15420045510586 - 3Dimensions: 2024-07-08 Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breas
• 15420045510593 - 3Dimensions: 2024-07-08 Selenia® Dimensions® Mobile digital mammography system is a mobile mammographic system used for capturing digital x-ray image
• 15420045510760 - Selenia Dimensions: 2024-07-08 Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breas
• 15420045511422 - Panther Fusion®: 2024-06-18 Cytomegalovirus (CMV) Primers ASR.