Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM— 510(k) K170816

Substantially Equivalent

Brainlab AG

FDA 510(k) clearance K170816 for Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM, Substantially Equivalent on 2017-09-26. Applicant: Brainlab AG.

Clearance details

Applicant: Brainlab AG
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2017-03-20
Decision date: 2017-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
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.