TOSHIBA SUPERCONDUCTING MRI SYSTEM Vantage Titan

GUDID 04987670101601

This device was previously sold by TOSHIBA MEDICAL SYSTEMS CORPORATION under the brand name TOSHIBA SUPERCONDUCTING MRI SYSTEM Vantage Titan. Effecti

CANON MEDICAL SYSTEMS CORPORATION

Full-body MRI system, superconducting magnet

• Primary Device ID: 04987670101601
• NIH Device Record Key: d3b7a1c9-0b87-4323-ae49-0ed990c77877
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TOSHIBA SUPERCONDUCTING MRI SYSTEM Vantage Titan
• Version Model Number: MRT-1510
• Company DUNS: 690575113
• Company Name: CANON MEDICAL SYSTEMS CORPORATION
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987670101601 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150427

FDA Product Code

• LNH: System, nuclear magnetic resonance imaging

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-02

On-Brand Devices [TOSHIBA SUPERCONDUCTING MRI SYSTEM Vantage Titan]

• 04987670102400: This device was previously sold by TOSHIBA MEDICAL SYSTEMS CORPORATION under the brand name TOSH
• 04987670101601: This device was previously sold by TOSHIBA MEDICAL SYSTEMS CORPORATION under the brand name TOS