Devices · Omega Medical Imaging, LLC

Soteria.AI

Omega Medical Imaging, LLC is listed for Soteria.AI (K212336). The FDA list gives November 17, 2021 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code OWB as “Interventional Fluoroscopic X-Ray System”: Interventional fluoroscopy openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K212336

Official FDA database record

Date of final decision

November 17, 2021

Company on the FDA list

Omega Medical Imaging, LLC

Lead panel

Radiology

Primary product code

OWB

openFDA device name for the code

Interventional Fluoroscopic X-Ray System

Device class

2

Regulation number

892.1650

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary