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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
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