EXCELART
FDA 510(k) clearance K990620 · decided 1999-05-14
Clearance details
- K-number
- K990620
- Device name
- EXCELART
- Applicant
- Toshiba America Mri, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-02-25
- Decision date
- 1999-05-14
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- LNH
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- S. San Francisco, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Magnetic Resonance Imaging Systems; Visart, Excelart / Excelart P2 / Excelart P3 / Excelar recall (Z-0986-05) | Toshiba American Med Sys Inc | 2005-07-13 |
| 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: Flexart, Visart and Excelart Models. recall (Z-0546-04) | Toshiba American Med Sys Inc | 2004-07-20 |
| Magnetic Resonance Imaging System Core Software, Software installed in all of the followin recall (Z-0937-04) | Toshiba American Med Sys Inc | 2004-07-20 |
| 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 |