FDA UDI
In Commercial Distribution
🇺🇸 United States
TOSHIBA SUPERCONDUCTING MRI SYSTEM Vantage Elan
DI: 04987670101632
·
Model: MRT-2020
·
CANON MEDICAL SYSTEMS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TOSHIBA SUPERCONDUCTING MRI SYSTEM Vantage Elan
- Primary DI
- 04987670101632
- Version / Model
- MRT-2020
- Company Name
- CANON MEDICAL SYSTEMS CORPORATION
- Labeler DUNS
- 690575113
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-03-02
- Public Version
- 2
- Public Version Date
- 2018-07-06
- Public Version Status
- New
- Public Device Record Key
- 65c948eb-8c66-4db1-9fc4-4d64e3e93abd
Device Description
This device was previously sold by TOSHIBA MEDICAL SYSTEMS CORPORATION under the brand name TOSHIBA SUPERCONDUCTING MRI SYSTEM Vantage Elan. Effective Jan 2018, the company name changed to CANON MEDICAL SYSTEMS CORPORATION. The device brand name is now Vantage Elan.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LNH | System, nuclear magnetic resonance imaging | Radiology | 892.1000 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04987670101632 | GS1 |
Customer Contacts
- Phone
- +1-8004211968
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K141472 | 000 |