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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 K243038
Device Name Salix Central
Applicant
Artrya Limited
1257 Hay Street
West Perth
Perth,  AU 6005
Applicant Contact Gabriela Quijada
Correspondent
Artrya Limited
1257 Hay Street
West Perth
Perth,  AU 6005
Correspondent Contact Gabriela Quijada
Regulation Number892.2050
Classification Product Code
QIH  
Date Received09/27/2024
Decision Date 03/27/2025
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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