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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
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