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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, Tomography, Computed
510(k) Number K233080
Device Name HealthFLD
Applicant
Nano-X AI Ltd.
Shefayim Commercial Center, PO Box 25
Shefayim,  IL 6099000
Applicant Contact Neta Sherman
Correspondent
Nano-X AI Ltd.
Shefayim Commercial Center, PO Box 25
Shefayim,  IL 6099000
Correspondent Contact Neta Sherman
Regulation Number892.1750
Classification Product Code
JAK  
Date Received09/26/2023
Decision Date 02/08/2024
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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