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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 K252649
Device Name TAP2D
Applicant
Nano-X Imaging , Ltd.
94 Em Hamoshavot Rd.
Brosh Bldg., Ofer Tech Park, P.O. Box 3486
Petah Tikva,  IL 4970602
Applicant Contact Ofir Koren
Correspondent
Nano-X Imaging , Ltd.
94 Em Hamoshavot Rd.
Brosh Bldg., Ofer Tech Park, P.O. Box 3486
Petah Tikva,  IL 4970602
Correspondent Contact Noa First
Regulation Number892.1740
Classification Product Code
IZF  
Subsequent Product Codes
LLZ   MQB  
Date Received08/21/2025
Decision Date 02/02/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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