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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
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