OmegaAI Image Viewer

System, Image Processing, Radiological

RamSoft Inc.

The following data is part of a premarket notification filed by Ramsoft Inc. with the FDA for Omegaai Image Viewer.

Pre-market Notification Details

Device IDK222476
510k NumberK222476
Device Name:OmegaAI Image Viewer
ClassificationSystem, Image Processing, Radiological
Applicant RamSoft Inc. 150 Wheeler Ave Toronto,  CA M4L3V4
ContactDeeksha Shukla
CorrespondentDeeksha Shukla
RamSoft Inc. 150 Wheeler Ave Toronto,  CA M4L3V4
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-08-16
Decision Date2022-11-17

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