K061871

Substantially Equivalent

LEICA MODEL FL800

Applicant: Leica Microsystems, Inc.
Product code: IZI
Advisory panel: Radiology
Date received: 2006-07-03
Decision date: 2006-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Park City, UT, US

Adverse events under product code IZI

product code IZI

Death: 9
Malfunction: 5,312
Total: 5,321

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.