Identity
- Trade Name
- TOSHIBA SUPERCONDUCTING MRI SYSTEM Vantage Titan FDA UDI
- Generic Name
- Full-body MRI system, superconducting magnet FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- MRT-1504 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987670102400 FDA UDI
- 510(k) Number
- K120638 FDA UDI
- FDA Product Code
- LNH FDA UDI
- GMDN Term
- Full-body MRI system, superconducting magnet FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1000 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Full-body MRI system, superconducting magnet
TOSHIBA SUPERCONDUCTING MRI SYSTEM Vantage Titan by Canon Medical Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Full-body MRI system, superconducting magnet.
- iTX Extremity 18 Flare Coil set 1.5T — Siemens Shenzhen Magnetic Resonance Ltd. · Class II
- MAGNETOM Sola Fit — Siemens Healthcare · Class II
- 8 channel wrist coil — Siemens Shenzhen Magnetic Resonance Ltd. · Class II
- Head/Neck 64 CS Coil 3T — Siemens Healthcare · Class II
- 1.5T HDxt Upgrade Kit — GE MEDICAL SYSTEMS, INC. · Class IIa
- Flex Large 8 Coil Set 1.5T — Siemens Shenzhen Magnetic Resonance Ltd. · Class II
- Flex small 4 MR coil set 3T — Siemens Healthcare · Class II
- InVision 1.5 Surgical Theatre — IMRIS Imaging, Inc. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Canon Medical Systems Corporation
Sources (1)
- FDA UDI 7084ecba-6b0e-4351-b6a7-0eb5fd9acb65 35 fields · synced Jun 6, 2026