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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, Mobile
510(k) Number K203782
Device Name Nanox Cart X-ray System
Applicant
Nano-X Imaging , Ltd.
Communications Center Bldg. C, Entrance 1
Neve Ilan,  IL 9085000
Applicant Contact Yuval Shapiro
Correspondent
Accelerated Device Approval Services
6800 SW 40th St., Suite 403
Ludlum,  FL  33155
Correspondent Contact Rafael Aguila
Regulation Number892.1720
Classification Product Code
IZL  
Date Received12/28/2020
Decision Date 04/01/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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