DeviceClearance

K083745

Substantially Equivalent

THE IC-PRO SYSTEM, MODEL VERSION 3.2

Applicant
Paieon, Inc.
Product code
IZI
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Rosh Haayin, IL
Download summary PDF View on FDA.gov ↗

Adverse events under product code IZI

product code IZI
Death
9
Malfunction
5,312
Total
5,321

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.