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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 K221624
Device Name Avenda Health AI Prostate Cancer Planning Software
Applicant
Avenda Health, Inc.
4130 Overland Avenue
Culver City,  CA  90230
Applicant Contact Brittany Berry-Pusey
Correspondent
Avenda Health, Inc.
4130 Overland Avenue
Culver City,  CA  90230
Correspondent Contact Brittany Berry-Pusey
Regulation Number892.2060
Classification Product Code
POK  
Date Received06/06/2022
Decision Date 11/22/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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