Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR
FDA 510(k) clearance K222968 · decided 2022-10-25
Clearance details
- K-number
- K222968
- Device name
- Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR
- Applicant
- Canon Medical Systems Corporation
- Decision
- Substantially Equivalent
- Date received
- 2022-09-27
- Decision date
- 2022-10-25
- Days to decision
- 28 days
- Clearance type
- Special
- 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 |
|---|---|---|
| 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 |
| MRI system: Vantage Orian, Vantage Fortian, Model: MRT-1550 recall (Z-1248-2024) | Canon Medical System, USA, INC. | 2024-03-04 |