FDA 510(k) Applications Submitted by John Newman

FDA 510(k) Number Submission Date Device Name Applicant
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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