IPLAN (IPLAN CRANIAL, IPLAN STEREOTAXY, IPLAN ENT, IPLAN CMF, IPLAN VIEW, IPLAN SPINE)— 510(k) K113732

Substantially Equivalent

Brainlab AG

FDA 510(k) clearance K113732 for IPLAN (IPLAN CRANIAL, IPLAN STEREOTAXY, IPLAN ENT, IPLAN CMF, IPLAN VIEW, IPLAN SPINE), Substantially Equivalent on 2012-05-07. Applicant: Brainlab AG.

Clearance details

Applicant: Brainlab AG
Product code: Code JAK
Advisory panel: Radiology
Date received: 2011-12-19
Decision date: 2012-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Feldkirchen, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code JAK

product code JAK

Death: 27
Injury: 571
Malfunction: 779
Total: 1,377

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.