DEVICE: TOSHIBA SUPERCONDUCTING MRI SYSTEM Vantage Titan (04987670102400)
Device Identifier (DI) Information
TOSHIBA SUPERCONDUCTING MRI SYSTEM Vantage Titan
MRT-1504
In Commercial Distribution
CANON MEDICAL SYSTEMS CORPORATION
MRT-1504
In Commercial Distribution
CANON MEDICAL SYSTEMS CORPORATION
This device was previously sold by TOSHIBA MEDICAL SYSTEMS CORPORATION under the brand name TOSHIBA SUPERCONDUCTING MRI SYSTEM Vantage Titan. Effective Jan 2018, the company name changed to CANON MEDICAL SYSTEMS CORPORATION. The device brand name is now Vantage Titan.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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37654 | Full-body MRI system, superconducting magnet |
A diagnostic general-purpose magnetic resonance imaging (MRI) system designed to scan any targeted area of the body (full-body imaging). This system includes a superconducting magnet assembly and can be fixed-location, mobile, or transportable. Some systems can perform MR spectroscopy or various real-time imaging procedures for MRI guided interventional, therapeutic, or surgical applications. The system is available in a variety of system gantry configurations including closed bore, open bore, and open-sided or other kinds of patient accessible designs.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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LNH | System, nuclear magnetic resonance imaging |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K120638 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
7084ecba-6b0e-4351-b6a7-0eb5fd9acb65
July 06, 2018
2
March 02, 2018
July 06, 2018
2
March 02, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1-8004211968
xxx@xxx.xxx
xxx@xxx.xxx