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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 K203280
Device Name Hepatica v1 (Hepatica v1.0.0)
Applicant
Perspectum Ltd.
5520 John Smith Drive
Oxford,  GB OX4 2LL
Applicant Contact Jaco Jacobs
Correspondent
Perspectum Ltd.
5520 John Smith Drive
Oxford,  GB OX4 2LL
Correspondent Contact Ioan Wigley
Regulation Number892.1000
Classification Product Code
LNH  
Date Received11/06/2020
Decision Date 01/12/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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