AYCAN WORKSTATION OSIRIX PRO— 510(k) K103546

Name: FDA 510(k) clearance K103546
Creator: U.S. Food and Drug Administration
Published: 2011-03-17

Substantially Equivalent

Aycan Digitalsysteme GmbH

FDA 510(k) clearance K103546 for AYCAN WORKSTATION OSIRIX PRO, Substantially Equivalent on 2011-03-17. Applicant: Aycan Digitalsysteme GmbH. Device class: 2.

Clearance details

Applicant: Aycan Digitalsysteme GmbH
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2010-12-02
Decision date: 2011-03-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Wuerzburg, DE

Download summary PDF View on FDA.gov ↗

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K122260 — AYCAN MOBILE2012-09-12
K063470 — AYCAN WORKSTATION OSIRIX2007-01-05

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.