Cleared Traditional

K063470 - AYCAN WORKSTATION OSIRIX

K063470 is an FDA 510(k) clearance for AYCAN WORKSTATION OSIRIX, manufactured by Aycan Digitalsysteme GmbH. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K063470 · Aycan Digitalsysteme GmbH · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2007
Decision
50d
Days
Class 2
Risk

K063470 is an FDA 510(k) clearance for the AYCAN WORKSTATION OSIRIX. 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 (Denton, US). The FDA issued a Cleared decision on January 5, 2007 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

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.

FDA 510(k) Submission Details - K063470

510(k) Number K063470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2006
Decision Date January 05, 2007
Days to Decision 50 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 107d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 2243
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K063470.
COR ANALYZER 1, VERSION 1.4
K063548 · Rcadia Medical Imaging , Ltd. · Jan 2007
NORDIC IMAGE CONTROL AND EVALUATION (NICE) SOFTWARE, VERSION 2.1
K063539 · Nordicicemedical AS · Jan 2007
SYNGO MI APPLICATIONS 2007A
K063826 · Siemens Medical Solutions USA, Inc. · Jan 2007
PHILIPS XD-S DIRECT RADIOGRAPHY WORKSTATION/PACKAGE
K063781 · Philips Medical Systems North America Co. · Jan 2007
NIO FUSION 4MP
K062905 · Barcoview · Dec 2006
CENTRICITY RADIOLOGY RA600, CARDIOLOGY CA1000 AND DIGITAL HARDCOPY
K063628 · Ge Healthcare Integrated IT Solutions · Dec 2006
K063470 · AYCAN WORKSTATION OSIRIX
Download PDF FDA Summary Aycan Digitalsysteme …