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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 K250650
Device Name SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option
Applicant
Arineta , Ltd.
15 Halamish St.
Caesarea,  IL 3088900
Applicant Contact Yaara Tirosh-Kamienchick
Correspondent
Arineta , Ltd.
15 Halamish St.
Caesarea,  IL 3088900
Correspondent Contact Tanya Shalem
Regulation Number892.1750
Classification Product Code
JAK  
Date Received03/04/2025
Decision Date 04/15/2025
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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