I -View™ Contrast Enhanced Digital Mammography

GUDID 15420045512016

Hologic, Inc.

Stationary mammographic x-ray system, digital

• Primary Device ID: 15420045512016
• NIH Device Record Key: 704f8433-cdbf-4d8a-950e-f94f310cf7f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: I -View™ Contrast Enhanced Digital Mammography
• Version Model Number: ASY-08109
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• 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	15420045512016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123873

FDA Product Code

• MUE: Full field digital, system, x-ray, mammographic

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: 2019-12-25
• Device Publish Date: 2019-12-17

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