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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interventional Fluoroscopic X-Ray System
510(k) Number K212159
Device Name Shield System
Applicant
Radiaction Ltd.
10 Hanechoshet St.
Tel Aviv,  IL 69710
Applicant Contact Jonathan Yifat
Correspondent
SFADC LLC
2425 L Street NW, Apt 307
Washington,  DC  20037
Correspondent Contact Susan Alpert
Regulation Number892.1650
Classification Product Code
OWB  
Date Received07/12/2021
Decision Date 03/30/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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