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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K252235
Device Name PVAD IQ Software
Applicant
Ultrasight , Ltd.
8 Pinhas St.
Ness Ziona,  IL 7403631
Applicant Contact Noa Avisar
Correspondent
Ultrasight , Ltd.
8 Pinhas St.
Ness Ziona,  IL 7403631
Correspondent Contact Noa Avisar
Regulation Number892.2050
Classification Product Code
QIH  
Date Received07/17/2025
Decision Date 12/18/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 Yes
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