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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
510(k) Number K241245
Device Name EchoSolv AS
Applicant
Echo IQ Ltd
Suite 2.114, Level 1
477 Pitt Street
Sydney,  AU 2000
Applicant Contact Dane Brescacin
Correspondent
Innolitics LLC
1101 West 34th St. #550
Austin,  TX  78705
Correspondent Contact J. David Giese
Regulation Number892.2060
Classification Product Code
POK  
Date Received05/03/2024
Decision Date 10/04/2024
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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