DeviceClearance

K182213

Substantially Equivalent

QT Ultrasound Breast Scanner - 1

Applicant
Qt Ultrasound, LLC
Product code
IYO
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Novato, CA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code IYO

product code IYO
Malfunction
3,339
Total
3,339

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.