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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 K202297
Device Name Aline Ablation Intelligence
Applicant
Mirada Medical Ltd
New Barclay House, 234 Botley Road
Oxford,  GB OX2 0HP
Applicant Contact David Clafton
Correspondent
THIRD PARTY REVIEW GROUP, LLC
25 Independence Blvd
Warren,  NJ  07059
Correspondent Contact Dave Yungvirt
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/13/2020
Decision Date 09/11/2020
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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