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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name image acquisition and/or optimization guided by artificial intelligence
510(k) Number K223347
Device Name UltraSight AI Guidance
Applicant
UltraSight Inc.
1 Hamada St.
Rehovot,  IL 7670301
Applicant Contact Davidi Vortman
Correspondent
Hogan Lovells US LLP
1735 Market Street, Floor 23
Philadelphia,  PA  19103
Correspondent Contact Janice M. Hogan
Regulation Number892.2100
Classification Product Code
QJU  
Date Received11/01/2022
Decision Date 07/24/2023
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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