510(k) Report

Devices descending from K902005

11 later devices reach Model B-200 C-Arm & Model C-300 Cardiac Table through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062647E-View Fluoroscopy System, Model CS-50Omega Medical Imaging, Inc.200610—
+2K070834CS-Series Fluoroscopy System, CS-10 Through CS-65 (11 Configurations)Omega Medical Imaging, Inc.20079—
+3K100102CS-Series-FPOmega Medical Imaging, Inc.20108—
+4K121293CS-Series-FP with 3030+OptionOmega Medical Imaging, LLC20127—
+5K182834CS-series-FP with Optional ROI Accessory CA-100SOmega Medical Imaging, LLC20194—
+5K171755CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy SystemOmega Medical Imaging, LLC20181—
+6K212890Nyquist.IQOmega Medical Imaging, LLC20210—
+6K212336Soteria.AIOmega Medical Imaging, LLC20211—
+6K201172CFP-3131, CFP-2222Mx Imaging, Inc.20200—
+6K191713CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™…Omega Medical Imaging, LLC20190—
+7K242488Soteria E-ViewOmega Medical Imaging, LLC20250—