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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 K213944
Device Name HealthOST
Applicant
NanoxAI Ltd.
Shefayim Commercial Center, PO Box 25
Shefayim,  IL 6099000
Applicant Contact Shlomit Cymbalista
Correspondent
NanoxAI Ltd.
Shefayim Commercial Center, PO Box 25
Shefayim,  IL 6099000
Correspondent Contact Neta Sherman
Regulation Number892.1750
Classification Product Code
JAK  
Date Received12/17/2021
Decision Date 04/22/2022
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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