SXT-60F/60M MOBILE C ARM X-RAY UNIT— 510(k) K896387
Substantially EquivalentToshiba America Medical Systems, In.C
FDA 510(k) clearance K896387 for SXT-60F/60M MOBILE C ARM X-RAY UNIT, Substantially Equivalent on 1990-02-23. Applicant: Toshiba America Medical Systems, In.C.
Clearance details
- Applicant
- Toshiba America Medical Systems, In.C
- Product code
- Code OXO
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tustin, CA, US
Adverse events under product code OXO
product code OXO- Death
- 6
- Injury
- 163
- Malfunction
- 2,099
- Other
- 1
- Total
- 2,269
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.