BODYFIX— 510(k) K013391

Substantially Equivalent

Medical Intelligence Medizintechnik GmbH

FDA 510(k) clearance K013391 for BODYFIX, Substantially Equivalent on 2002-01-11. Applicant: Medical Intelligence Medizintechnik GmbH.

Clearance details

Applicant: Medical Intelligence Medizintechnik GmbH
Product code: Code IYE
Advisory panel: Radiology
Date received: 2001-10-15
Decision date: 2002-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Schwabmunchen, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYE

product code IYE

Malfunction: 455
Other: 3
Total: 458

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.