K252579

Substantially Equivalent

Orthoscan TAU MVP Mini C-Arm System

Applicant
Ziehm-Orthoscan, Inc.
Product code
OXO
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Scottsdale, AZ, 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.