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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
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