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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 K202526
Device Name OmniTom Elite
Applicant
NeuroLogica Corporation, a subsidiary of Samsung Electronics
14 Electronics Avenue
Danvers,  MA  01923
Applicant Contact Ninad Gujar
Correspondent
NeuroLogica Corporation, a subsidiary of Samsung Electronics
14 Electronics Avenue
Danvers,  MA  01923
Correspondent Contact Ninad Gujar
Regulation Number892.1750
Classification Product Code
JAK  
Date Received09/01/2020
Decision Date 12/23/2020
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
Recalls CDRH Recalls
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