Cleared Special

K103546 - AYCAN WORKSTATION OSIRIX PRO

K103546 is an FDA 510(k) clearance for AYCAN WORKSTATION OSIRIX PRO, manufactured by Aycan Digitalsysteme GmbH. The device is a Class 2 Radiology device with product code LLZ cleared through the Special 510(k) pathway after a 105-day FDA review.

K103546 · Aycan Digitalsysteme GmbH · Radiology device
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Mar 2011
Decision
105d
Days
Class 2
Risk

K103546 is an FDA 510(k) clearance for the AYCAN WORKSTATION OSIRIX PRO. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Aycan Digitalsysteme GmbH (Wuerzburg, DE). The FDA issued a Cleared decision on March 17, 2011 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Aycan Digitalsysteme GmbH devices

FDA 510(k) Submission Details - K103546

510(k) Number K103546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2010
Decision Date March 17, 2011
Days to Decision 105 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 107d · This submission: 105d
Pathway characteristics
Modification to existing cleared device.

LLZ Device Classification - Class 2, Special Controls

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - LLZ System, Image Processing, Radiological

All 1270
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