UNIFI™ IMAGE QUALITY ASSIST SOFTWARE

GUDID 15420045512689

Hologic, Inc.

Stationary mammographic x-ray system, digital

• Primary Device ID: 15420045512689
• NIH Device Record Key: dfe03ba8-d3e3-4722-b9a1-31def80765ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNIFI™ IMAGE QUALITY ASSIST SOFTWARE
• Version Model Number: UNIFI IMAGE QUALITY ASSIST MOTION
• 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	15420045512689 [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: 2021-06-10
• Device Publish Date: 2021-06-02

On-Brand Devices [UNIFI™ IMAGE QUALITY ASSIST SOFTWARE]

• 15420045512696: UNIFI IMAGE QUALITY ASSIST POSITIONING
• 15420045512689: UNIFI IMAGE QUALITY ASSIST MOTION