Claritas IPET

System, Image Processing, Radiological

Claritas HealthTech Pte Ltd

The following data is part of a premarket notification filed by Claritas Healthtech Pte Ltd with the FDA for Claritas Ipet.

Pre-market Notification Details

Device IDK213140
510k NumberK213140
Device Name:Claritas IPET
ClassificationSystem, Image Processing, Radiological
Applicant Claritas HealthTech Pte Ltd 20A Tanjong Pagar Road Singapore,  SG 088443
ContactDevika Dutt
CorrespondentDevika Dutt
Claritas HealthTech Pte Ltd 20A Tanjong Pagar Road Singapore,  SG 088443
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-27
Decision Date2021-12-22

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