Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout— 510(k) K252476

Substantially Equivalent

Brainlab AG

FDA 510(k) clearance K252476 for Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout, Substantially Equivalent on 2025-10-16. Applicant: Brainlab AG.

Clearance details

Applicant: Brainlab AG
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2025-08-07
Decision date: 2025-10-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Munich, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.