Vantage Titan 3T, MRT-3010, V2.5
FDA 510(k) clearance K191128 · decided 2019-06-26
Clearance details
- K-number
- K191128
- Device name
- Vantage Titan 3T, MRT-3010, V2.5
- Applicant
- Canon Medical Systems Corporation
- Decision
- Substantially Equivalent
- Date received
- 2019-04-29
- Decision date
- 2019-06-26
- Days to decision
- 58 days
- Clearance type
- Traditional
- Product code
- LNH
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Otawara-Shi, JP
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| VANTAGE TITAN 3T Model MRT-3010/MEXL-3010 recall (Z-1018-2026) | Canon Medical System, USA, INC. | 2026-01-13 |
| MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-1520), Vantag recall (Z-2041-2024) | Canon Medical System, USA, INC. | 2024-06-09 |