TOSHIBA EXCELART VANTAGE XGV/AGV MRI DIAGNOSTIC SYSTEM, MODELS MRT-1503/P3 AND MRT-1503/P2
FDA 510(k) clearance K032490 · decided 2003-08-21
Clearance details
- K-number
- K032490
- Device name
- TOSHIBA EXCELART VANTAGE XGV/AGV MRI DIAGNOSTIC SYSTEM, MODELS MRT-1503/P3 AND MRT-1503/P2
- Applicant
- Toshiba America Medical Systems, In.C
- Decision
- Substantially Equivalent
- Date received
- 2003-08-12
- Decision date
- 2003-08-21
- Days to decision
- 9 days
- Clearance type
- Traditional
- Product code
- LNH
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Tustin, CA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| EXCELART Vantage, Atlas, and Titan MRI Systems, MRT-1503 and MRT-1504. Imaging of the Whol recall (Z-2278-2012) | Toshiba American Medical Systems Inc | 2012-08-28 |
| Toshiba Excelart VANTAGE Model MRT-1503, Magnetic Resonance Imaging Systems, Regulation Nu recall (Z-0281-06) | Toshiba American Med Sys Inc | 2005-12-14 |
| Excelart (tm) VANTAGE P2 & P3, Magnetic Resonance Imaging System, recall (Z-0061-05) | Toshiba American Med Sys Inc | 2004-11-02 |