APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM MODEL SSA-790A VERSION 4.0— 510(k) K091295
Substantially EquivalentToshiba America Medical Systems, In.C
FDA 510(k) clearance K091295 for APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM MODEL SSA-790A VERSION 4.0, Substantially Equivalent on 2009-05-15. Applicant: Toshiba America Medical Systems, In.C.
Clearance details
- Applicant
- Toshiba America Medical Systems, In.C
- Product code
- Code ITX
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tustin, CA, US
Adverse events under product code ITX
product code ITX- Death
- 6
- Injury
- 137
- Malfunction
- 2,036
- Total
- 2,179
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.