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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 K230370
Device Name SpotLight/SpotLight Duo (with DLIR option)
Applicant
Arineta Ltd.
15 Halamish St.
Caesarea,  IL 3088900
Applicant Contact Tanya Shalem
Correspondent
Hogan Lovells US LLP
555 Thirteenth Street, NW
Washington,  DC  20004 -1109
Correspondent Contact John Smith
Regulation Number892.1750
Classification Product Code
JAK  
Date Received02/10/2023
Decision Date 10/13/2023
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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