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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
Recalls CDRH Recalls
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