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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 K261125
Device Name BodyTom 64 (NL4100); OmniTom Elite (NL5000)
Applicant
Samsung HME America, Inc., dba NeuroLogica Corp.
14 Electronics Ave.
Danvers,  MA  01923
Applicant Contact Ninad Gujar
Correspondent
Samsung HME America, Inc., dba NeuroLogica Corp.
14 Electronics Ave.
Danvers,  MA  01923
Correspondent Contact Ninad Gujar
Regulation Number892.1750
Classification Product Code
JAK  
Date Received04/06/2026
Decision Date 09/22/2026
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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