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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 K222625
Device Name Shield System
Applicant
Radiaction , Ltd.
10 Hanechoshet St.
Tel Aviv,  IL 6971072
Applicant Contact Jonathan Yifat
Correspondent
Sfadc, LLC
2425 L St. NW
Apt. 307
Washington,  DC  20037
Correspondent Contact Susan Alpert
Regulation Number892.1650
Classification Product Code
OWB  
Date Received08/31/2022
Decision Date 09/30/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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