LEICA FL800— 510(k) K080612

Substantially Equivalent

Leica Microsystems (Schweiz) AG

FDA 510(k) clearance K080612 for LEICA FL800, Substantially Equivalent on 2008-05-09. Applicant: Leica Microsystems (Schweiz) AG.

Clearance details

Applicant: Leica Microsystems (Schweiz) AG
Product code: Code IZI
Advisory panel: Radiology
Date received: 2008-03-04
Decision date: 2008-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orange, CA, US

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, 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.