AYCAN MOBILE— 510(k) K122260

Substantially Equivalent

Aycan Digitalsysteme GmbH

FDA 510(k) clearance K122260 for AYCAN MOBILE, Substantially Equivalent on 2012-09-12. Applicant: Aycan Digitalsysteme GmbH.

Clearance details

Applicant: Aycan Digitalsysteme GmbH
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2012-07-27
Decision date: 2012-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wuerzburg, 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.