LODOX, MODEL BASELINE— 510(k) K013999

Substantially Equivalent

Lodox Systems (Pty), Ltd.

FDA 510(k) clearance K013999 for LODOX, MODEL BASELINE, Substantially Equivalent on 2002-08-06. Applicant: Lodox Systems (Pty), Ltd..

Clearance details

Applicant: Lodox Systems (Pty), Ltd.
Product code: Code JAK
Advisory panel: Radiology
Date received: 2001-12-04
Decision date: 2002-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

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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.