GLOW800— 510(k) K181537

Substantially Equivalent

Leica Microsystems (Schweiz) AG

FDA 510(k) clearance K181537 for GLOW800, Substantially Equivalent on 2018-09-07. Applicant: Leica Microsystems (Schweiz) AG.

Clearance details

Applicant: Leica Microsystems (Schweiz) AG
Product code: Code IZI
Advisory panel: Radiology
Date received: 2018-06-11
Decision date: 2018-09-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Heerbrugg, CH

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.