K896387

Substantially Equivalent

SXT-60F/60M MOBILE C ARM X-RAY UNIT

Applicant
Toshiba America Medical Systems, In.C
Product code
OXO
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Tustin, CA, US
Download summary PDF View on FDA.gov ↗

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.