FAXITRON ULTRAFOCUS

GUDID 15420045514898

Hologic, Inc.

Tissue specimen x-ray system IVD

• Primary Device ID: 15420045514898
• NIH Device Record Key: aa17b381-5fdb-4a11-96f9-b2ea8df14360
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FAXITRON ULTRAFOCUS
• Version Model Number: ULTRAFOCUS 23x29
• 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: false
• Serial Number: true
• 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	15420045514898 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082432

FDA Product Code

• MWP: Cabinet, x-ray system

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: 2022-07-20
• Device Publish Date: 2022-07-12

Devices Manufactured by Hologic, Inc.

• 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.
• 15420045517851 - Selenia® Dimensions®: 2025-07-25 The Selenia® Dimensions® digital mammography system generates digital mammographic images that can be used for screening and
• 15420045517882 - Selenia® Dimensions®: 2025-07-25 The Selenia® Dimensions® digital mammography system generates digital mammographic images that can be used for screening and
• 15420045517899 - Selenia® Dimensions®: 2025-07-25 The Selenia® Dimensions® digital mammography system generates digital mammographic images that can be used for screening and
• 15420045517905 - Selenia® Dimensions®: 2025-07-25 The Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the b