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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 K213941
Device Name Annalise Enterprise CXR Triage Pneumothorax
Level 21, 60 Margaret Street
Sydney,  AU 2000
Applicant Contact Eric Qin
Level 21, 60 Margaret Street
Sydney,  AU 2000
Correspondent Contact Michele Houldsworth
Regulation Number892.2080
Classification Product Code
Date Received12/16/2021
Decision Date 02/24/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No