510(k) Report

Devices descending from K182834

4 later devices reach CS-series-FP with Optional ROI Accessory CA-100S through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212890Nyquist.IQOmega Medical Imaging, LLC20210—
+1K212336Soteria.AIOmega Medical Imaging, LLC20211—
+1K191713CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™…Omega Medical Imaging, LLC20190—
+2K242488Soteria E-ViewOmega Medical Imaging, LLC20250—