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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radiological Image Processing Software For Radiation Therapy
510(k) Number K181572
Device Name Workflow Box
Applicant
Mirada Medical Ltd.
Oxford Centre for Innovation, New Road
Oxford,  GB ox1 iby
Applicant Contact Gwilym Owen
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Mark Job
Regulation Number892.2050
Classification Product Code
QKB  
Date Received06/14/2018
Decision Date 07/10/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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