Faxitron CT FAX-019

GUDID 15420045514911

Hologic, Inc.

Specimen x-ray system IVD Specimen x-ray system IVD Specimen x-ray system IVD Specimen x-ray system IVD Specimen x-ray system IVD Specimen x-ray system IVD Specimen x-ray system IVD Specimen x-ray system IVD Specimen x-ray system IVD Specimen x-ray system IVD Specimen x-ray system IVD Specimen x-ray system IVD Specimen x-ray system IVD Specimen x-ray system IVD Specimen x-ray system IVD Specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD

• Primary Device ID: 15420045514911
• NIH Device Record Key: c0e1d56f-ed90-4762-8bbf-6be26cd16131
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Faxitron CT
• Version Model Number: VISION CT
• Catalog Number: FAX-019
• 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	15420045514911 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173309

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: 2021-10-15
• Device Publish Date: 2021-10-07

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