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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 K242395
Device Name Nanox.ARC
Applicant
Nano-X Imaging , Ltd.
94 Em Hamoshavot Rd.
Brosh Bldg., Ofer Tech Park, P.O. Box 3486
Petah Tikva,  IL 4970602
Applicant Contact Erez Meltzer
Correspondent
Nano-X Imaging , Ltd.
94 Em Hamoshavot Rd.
Brosh Bldg., Ofer Tech Park, P.O. Box 3486
Petah Tikva,  IL 4970602
Correspondent Contact Odelia Maron
Regulation Number892.1740
Classification Product Code
IZF  
Subsequent Product Code
MQB  
Date Received08/13/2024
Decision Date 12/04/2024
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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