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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K202170
Device Name LiverMultiScan
Applicant
Perspectum LTD
Gemini One, 5520 John Smith Drive
Oxford,  GB OX4 2LL
Applicant Contact Jaco Jacobs
Correspondent
Perspectum LTD
Gemini One, 5520 John Smith Drive
Oxford,  GB OX4 2LL
Correspondent Contact Jaco Jacobs
Regulation Number892.1000
Classification Product Code
LNH  
Date Received08/03/2020
Decision Date 10/02/2020
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
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