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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 K212470
Device Name iRAD
Applicant
Claritas HealthTech Pte Ltd
20A Tanjong Pagar Road
Singapore,  SG 088443
Applicant Contact Devika Dutt
Correspondent
Claritas HealthTech Pte Ltd
20A Tanjong Pagar Road
Singapore,  SG 088443
Correspondent Contact Devika Dutt
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/06/2021
Decision Date 10/20/2021
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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