Examion X-AQS— 510(k) K170729

Substantially Equivalent

Examion GmbH

FDA 510(k) clearance K170729 for Examion X-AQS, Substantially Equivalent on 2017-07-18. Applicant: Examion GmbH.

Clearance details

Applicant: Examion GmbH
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2017-03-09
Decision date: 2017-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fellbach, 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.