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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 K102687
Device Name MIRADA RT
Original Applicant
MIRADA MEDICAL LTD.
mill street
innovation house
oxford, oxfordshire,  GB ox2 0jx
Original Contact gwilym owen
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/17/2010
Decision Date 10/04/2010
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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