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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 K213140
Device Name Claritas iPET
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 Received09/27/2021
Decision Date 12/22/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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