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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 K250831
Device Name Annalise Enterprise
Applicant
Annalise-Ai
Level P, 24 Campbell St.
Sydney,  AU 2000
Applicant Contact Haylee Bosshard
Correspondent
Annalise-Ai
Level P, 24 Campbell St.
Sydney,  AU 2000
Correspondent Contact Haylee Bosshard
Regulation Number892.2080
Classification Product Code
QFM  
Subsequent Product Code
QAS  
Date Received03/19/2025
Decision Date 04/23/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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