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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K243005
Device Name AudaxCeph Cephalogram Analysis Software
Applicant
Audax D.O.O.
Tehnološki Park 18c, 1000
Ljubljana,  SI
Applicant Contact Peter Kobal
Correspondent
Trellis Enterprises, LLC
P.O. Box 1406
Boulder,  UT  84716
Correspondent Contact Josh Ellis
Regulation Number892.2050
Classification Product Code
QIH  
Date Received09/26/2024
Decision Date 05/30/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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