510(k) Report

Devices descending from K021153

13 later devices reach Goldway Digital Video Colposcope Imaging System, Model #SLC-2000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160341Colposcope SystemXuzhou Kernel Medical Equipment Co., Ltd.20160—
+1K151878Video ColposcopeEdan Instruments, Inc.20152—
+1K122311GC-3000E Digital ColposcopeShenzhen Goldcare Meditech Co., Ltd.20130—
+1K122973AL-106, AL-106SA and AL-106B Medgyn Digital Video ColposcopeMedgyn Products, Inc.20137—
+1K092433DYSISForth Photonics Hellas SA20110—
+2K190187Gynescope SystemIllumigyn, Ltd.20190—
+2K182764Biop Digital ColposcopeBiop Medical, Ltd.20180—
+2K181034Pocket Colposcope SystemHadleigh Health Technologies, LLC20181—
+2K161871EVA (Enhanced Visual Assessment) SystemMobileodt, Ltd.20161—
+2K140754Cooper Surgical Leisegang Colposcope SystemCooperSurgical, Inc.20141—
+2K132423The GynocularGynius AB20140—
+3K233043Smart Scope® CXPeriwinkle Technologies Pvt., Ltd.20240—
+3K202915IRIS Thermocoagulator and Digital ColposcopeLiger Medical, LLC20210—