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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K183133
Device Name MRCP+ v1.0
Applicant
Perspectum Diagnostics Ltd
23-38 Hythe Bridge Street
Oxford,  GB OX1 2ET
Applicant Contact Jaco Jacobs
Correspondent
Perspectum Diagnostics Ltd
23-38 Hythe Bridge Street
Oxford,  GB OX1 2ET
Correspondent Contact Jaco Jacobs
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/13/2018
Decision Date 01/09/2019
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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