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FDA 510(k) Applications Submitted by OMEGA MEDICAL IMAGING, LLC
FDA 510(k) Number
Submission Date
Device Name
Applicant
K121293
04/30/2012
CS-SERIES-FP WITH 3030+OPTION
OMEGA MEDICAL IMAGING, LLC
K171755
06/13/2017
CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System
Omega Medical Imaging, LLC
K191713
06/26/2019
CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShieldÖ (ROI Assembly)
Omega Medical Imaging, LLC
K212336
07/27/2021
Soteria.AI
Omega Medical Imaging, LLC
K212890
09/10/2021
Nyquist.IQ
Omega Medical Imaging, LLC
K182834
10/09/2018
CS-series-FP with Optional ROI Accessory CA-100S
Omega Medical Imaging, LLC
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