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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 K211356
Device Name GIQuant
Applicant
Motilent, Ltd.
Idealondon, 69 Wilson St.
London,  GB EC2A 2BB
Applicant Contact Ian Knott
Correspondent
Motilent, Ltd.
Idealondon, 69 Wilson St.
London,  GB EC2A 2BB
Correspondent Contact Ian Knott
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/03/2021
Decision Date 11/08/2021
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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