Selenia Dimensions C-View Software

GUDID 15420045500020

Hologic, Inc.

Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software

• Primary Device ID: 15420045500020
• NIH Device Record Key: 6a4529dd-4754-4556-a120-2a20b57360db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Selenia Dimensions C-View Software
• Version Model Number: C-View
• 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: 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	15420045500020 [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: 2014-09-05

Devices Manufactured by Hologic, Inc.

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• 15420045510593 - 3Dimensions: 2024-07-08 Selenia® Dimensions® Mobile digital mammography system is a mobile mammographic system used for capturing digital x-ray image
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