K103597

Substantially Equivalent

DX-D 100

Applicant
Agfa Healthcare N.V.
Product code
IZL
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Greenville, SC, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code IZL

product code IZL
Other
3
Total
3

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.