Cleared Traditional

Soteria E-View

K242488 · Omega Medical Imaging, LLC · Radiology
Jan 2025
Decision
138d
Days
Class 2
Risk

About This 510(k) Submission

K242488 is an FDA 510(k) clearance for the Soteria E-View, a System, X-ray, Fluoroscopic, Image-intensified (Class II — Special Controls, product code JAA), submitted by Omega Medical Imaging, LLC (Sanford, US). The FDA issued a Cleared decision on January 6, 2025, 138 days after receiving the submission on August 21, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number K242488 FDA.gov
FDA Decision Cleared SESE
Date Received August 21, 2024
Decision Date January 06, 2025
Days to Decision 138 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code JAA — System, X-ray, Fluoroscopic, Image-intensified
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1650

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