NaviSuite SSI Edition— 510(k) K163119

Substantially Equivalent

Medcom GmbH

FDA 510(k) clearance K163119 for NaviSuite SSI Edition, Substantially Equivalent on 2017-05-01. Applicant: Medcom GmbH.

Clearance details

Applicant: Medcom GmbH
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2016-11-08
Decision date: 2017-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Darmstadt, 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.