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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radiological Computer-Assisted Prioritization Software For Lesions
510(k) Number K222179
Device Name Annalise Enterprise CXR Triage Trauma
Applicant
Annalise-AI Pty Ltd
Level P, 24 Campbell St
Sydney,  AU 2000
Applicant Contact Minta Chen
Correspondent
Annalise-AI Pty Ltd
Level P, 24 Campbell St
Sydney,  AU 2000
Correspondent Contact Haylee Bosshard
Regulation Number892.2080
Classification Product Code
QFM  
Subsequent Product Code
QAS  
Date Received07/22/2022
Decision Date 03/28/2023
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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