CT SCANNER

GUDID 04987670106538

CANON INC.

Full-body CT system

• Primary Device ID: 04987670106538
• NIH Device Record Key: f0eef644-bbe0-43ca-8c58-34c16c9409c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CT SCANNER
• Version Model Number: TSX-301B
• Company DUNS: 690549662
• Company Name: CANON 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: 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

Customer Support Contacts

• Phone: +1-8004211968
• Email: xxx@xxx.xxx
• Phone: +1-8004211968
• Email: xxx@xxx.xxx
• Phone: +1-8004211968
• Email: xxx@xxx.xxx
• Phone: +1-8004211968
• Email: xxx@xxx.xxx
• Phone: +1-8004211968
• Email: xxx@xxx.xxx
• Phone: +1-8004211968
• Email: xxx@xxx.xxx
• Phone: +1-8004211968
• Email: xxx@xxx.xxx
• Phone: +1-8004211968
• Email: xxx@xxx.xxx
• Phone: +1-8004211968
• Email: xxx@xxx.xxx
• Phone: +1-8004211968
• Email: xxx@xxx.xxx
• Phone: +1-8004211968
• Email: xxx@xxx.xxx
• Phone: +1-8004211968
• Email: xxx@xxx.xxx
• Phone: +1-8004211968
• Email: xxx@xxx.xxx
• Phone: +1-8004211968
• Email: xxx@xxx.xxx
• Phone: +1-8004211968
• Email: xxx@xxx.xxx
• Phone: +1-8004211968
• Email: xxx@xxx.xxx
• Phone: +1-8004211968
• Email: xxx@xxx.xxx
• Phone: +1-8004211968
• Email: xxx@xxx.xxx
• Phone: +1-8004211968
• Email: xxx@xxx.xxx

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987670106538 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120546

FDA Product Code

• JAK: System, x-ray, tomography, computed

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: 2026-03-09
• Device Publish Date: 2026-03-01

On-Brand Devices [CT SCANNER]

• 04987670106538: TSX-301B
• 04987670104701: TSX-501R