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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, imaging, pulsed echo, ultrasonic
510(k) Number K213620
Device Name ATUSA™ Automated 3D Breast Ultrasound System
iSono Health, Inc.
395 Oyster Point Blvd., Suite 501
South San Fransisco,  CA  94080
Applicant Contact Shadi Saberi
Compliance and Regulatory Services LLC
3771 Southbrook Dr
Dayton,  OH  45430
Correspondent Contact Daniel Lehtonen
Regulation Number892.1560
Classification Product Code
Subsequent Product Code
Date Received11/16/2021
Decision Date 04/22/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No