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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic
510(k) Number K261132
Device Name Healium Intelliscan LX192LC
Applicant
Healium Intelliscan Corporation
26 Broadway
Suite 934-G68
New York, Ny,  NY  10004
Applicant Contact Biju Jacob
Correspondent
Medicsense USA, LLC
291 Hillside Ave.
Somerset,  MA  02726
Correspondent Contact George Hattub
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received04/06/2026
Decision Date 05/05/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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