DeviceClearance

K980851

Substantially Equivalent

GALAXY INTRAVASCULAR ULTRASOUND SYSTEM, MODEL I5028

Applicant
Boston Scientific Corp
Product code
IYO
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Jose, 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.