EXCELART WITH PIANISSIMO XG/AG SPIN EDITION, MODEL MRT-1501/P3, P2
FDA 510(k) clearance K023511 · decided 2002-11-05
Clearance details
- K-number
- K023511
- Device name
- EXCELART WITH PIANISSIMO XG/AG SPIN EDITION, MODEL MRT-1501/P3, P2
- Applicant
- Toshiba America Medical Systems, In.C
- Decision
- Substantially Equivalent
- Date received
- 2002-10-21
- Decision date
- 2002-11-05
- Days to decision
- 15 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 |
|---|---|---|
| Magnetic Resonance Imaging Systems under the following names: Visart Excelart Excelart P2 recall (Z-0270-05) | Toshiba American Med Sys Inc | 2004-12-02 |
| Magnetic Resonance Imaging System(s) Visart and Exelart P2/ Exelart P3/ Exelart SPIN and E recall (Z-1045-04) | Toshiba American Med Sys Inc | 2004-07-20 |