510(k) K242488

Soteria E-View by Omega Medical Imaging, LLC — Product Code JAA

K242488 is an FDA 510(k) premarket notification submitted by Omega Medical Imaging, LLC for the device "Soteria E-View". The FDA issued a decision of Substantially Equivalent on January 6, 2025. The device falls under product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified), a Class II device regulated under 21 CFR 892.1650. Omega Medical Imaging, LLC has at least 10 other 510(k) clearances on record.