510(k) Report

Devices descending from K100102

8 later devices reach CS-Series-FP through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121293CS-Series-FP with 3030+OptionOmega Medical Imaging, LLC20127—
+2K182834CS-series-FP with Optional ROI Accessory CA-100SOmega Medical Imaging, LLC20194—
+2K171755CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy SystemOmega Medical Imaging, LLC20181—
+3K212890Nyquist.IQOmega Medical Imaging, LLC20210—
+3K212336Soteria.AIOmega Medical Imaging, LLC20211—
+3K201172CFP-3131, CFP-2222Mx Imaging, Inc.20200—
+3K191713CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™…Omega Medical Imaging, LLC20190—
+4K242488Soteria E-ViewOmega Medical Imaging, LLC20250—