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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
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