Medical Device Manufacturer · US , Sanford , FL

Omega Medical Imaging, LLC - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 2012

Recent clearances: Soteria E-View, Nyquist.IQ, Soteria.AI

7

Total

7

Cleared

0

Denied

FDA 510(k) Regulatory Record - Omega Medical Imaging, LLC Radiology ✕

7 devices

1-7 of 7

Cleared Jan 06, 2025

Radiology · 138d

Cleared Dec 13, 2021

Radiology · 94d

Cleared Nov 17, 2021

Radiology · 113d

Cleared Oct 04, 2019

CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S /...

Radiology · 100d

Cleared Mar 29, 2019

CS-series-FP with Optional ROI Accessory CA-100S

Radiology · 171d

Cleared Feb 09, 2018

CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy...

Radiology · 241d

Cleared Jul 26, 2012

CS-SERIES-FP WITH 3030+OPTION

Radiology · 87d