AQUILION CT SCANNER, MODEL TSX-101A
FDA 510(k) clearance K982265 · decided 1998-08-26
Clearance details
- K-number
- K982265
- Device name
- AQUILION CT SCANNER, MODEL TSX-101A
- Applicant
- Toshiba America Medical Systems, In.C
- Decision
- Substantially Equivalent
- Date received
- 1998-06-29
- Decision date
- 1998-08-26
- Days to decision
- 58 days
- Clearance type
- Traditional
- Product code
- JAK
- Device class
- 2
- Regulation number
- 892.1750
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Tustin, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Toshiba America Medical Systems (TAMS) Aquilion 32 CT system, computed tomography x-ray sy recall (Z-1707-2008) | Toshiba American Med Sys Inc | 2008-09-29 |
| Toshiba America Medical Systems (TAMS) Aquilion 64 CT system, computed tomography x-ray sy recall (Z-1708-2008) | Toshiba American Med Sys Inc | 2008-09-29 |
| Computed Tomography, Models TSX-101A and TSX-021A. recall (Z-1031-04) | Toshiba American Med Sys Inc | 2004-07-20 |