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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 K250850
Device Name Nanox.ARC X
Applicant
Nano-x Imaging Ltd.
94 Em Hamoshavot Road, Brosh building, Ofer Tech Park,
PO Box 3486
Petah Tikva,  IL 4970602
Applicant Contact Ofir Koren
Correspondent
Nano-x Imaging Ltd.
94 Em Hamoshavot Road, Brosh building, Ofer Tech Park,
PO Box 3486
Petah Tikva,  IL 4970602
Correspondent Contact Noa First
Regulation Number892.1740
Classification Product Code
IZF  
Subsequent Product Code
MQB  
Date Received03/20/2025
Decision Date 04/16/2025
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		 No
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