Soteria.AI

Interventional Fluoroscopic X-ray System

Omega Medical Imaging, LLC

The following data is part of a premarket notification filed by Omega Medical Imaging, Llc with the FDA for Soteria.ai.

Pre-market Notification Details

Device IDK212336
510k NumberK212336
Device Name:Soteria.AI
ClassificationInterventional Fluoroscopic X-ray System
Applicant Omega Medical Imaging, LLC 3400 St. Johns Parkway, Suite 1020 Sanford,  FL  32771
ContactJohn Newman
CorrespondentJohn Newman
Omega Medical Imaging, LLC 3400 St. Johns Parkway, Suite 1020 Sanford,  FL  32771
Product CodeOWB  
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-27
Decision Date2021-11-17

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