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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 K213960
Device Name LiverMultiScan v5 (LMSv5)
Applicant
Perspectum
Gemini One
5520 John Smith Drive
Oxford,  GB OX 2LL
Applicant Contact Wigley Ioan
Correspondent
Perspectum
Gemini One
5520 John Smith Drive
Oxford,  GB OX 2LL
Correspondent Contact Wigley Ioan
Regulation Number892.1000
Classification Product Code
LNH  
Date Received12/17/2021
Decision Date 09/06/2022
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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