MODEL TSX-301B AQUILION CT SYSTEM— 510(k) K083282
Substantially EquivalentToshiba America Medical Systems, In.C
FDA 510(k) clearance K083282 for MODEL TSX-301B AQUILION CT SYSTEM, Substantially Equivalent on 2008-12-12. Applicant: Toshiba America Medical Systems, In.C.
Clearance details
- Applicant
- Toshiba America Medical Systems, In.C
- Product code
- Code JAK
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tustin, CA, US
Adverse events under product code JAK
product code JAK- Death
- 27
- Injury
- 571
- Malfunction
- 779
- Total
- 1,377
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.