3Dimensions

GUDID 15420045507272

Hologic, Inc.

Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital

• Primary Device ID: 15420045507272
• NIH Device Record Key: c1ddc7ba-dd8b-4825-be66-173902fbab12
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3Dimensions
• Version Model Number: CLARITY HD 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	15420045507272 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-07-14

On-Brand Devices [3Dimensions]

• 15420045508033: ASY-10636-3D
• 15420045508026: ASY-10636-2D
• 15420045508019: ASY-10559
• 15420045507296: 3DIMENSIONS SOFTWARE
• 15420045507289: INTELLIGENT 2D SOFTWARE
• 15420045507272: CLARITY HD SOFTWARE
• 15420045510395: ASY-11748-3D
• 15420045511897: ASY-11748-CHD
• 15420045510388: ASY-11748-2D