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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 K231929
Device Name iQ-solutions
Applicant
Sydney Neuroimaging Analysis Centre Pty Ltd
Lvl 1, 94 Mallett Street
Camperdown,  AU 2050
Applicant Contact Chenyu Wang
Correspondent
Pharmalex Pty Ltd
Suite 10.04, 1 Chandos Street
St Leonards,  AU 2064
Correspondent Contact Belinda Dowsett
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Code
LLZ  
Date Received06/30/2023
Decision Date 12/18/2023
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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