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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K220034
Device Name NEUROShield
Applicant
In-Med Prognostics L3C
4918 September Street
San Diego,  CA  92110
Applicant Contact Latha Poonamalle
Correspondent
In-Med Prognostics L3C
4918 September Street
San Diego,  CA  92110
Correspondent Contact Latha Poonamallee
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received01/05/2022
Decision Date 09/14/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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