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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomographic
510(k) Number K222934
Device Name Nanox.ARC
Applicant
Nano-X Imaging , Ltd.
Communications Center, Bldg. C, Entrance 1
Neve Ilan,  IL 9085000
Applicant Contact Erez Meltzer
Correspondent
Nano-X Imaging , Ltd.
Communications Center, Bldg. C, Entrance 1
Neve Ilan,  IL 9085000
Correspondent Contact Odelia Maron
Regulation Number892.1740
Classification Product Code
IZF  
Subsequent Product Code
MQB  
Date Received09/26/2022
Decision Date 04/28/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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