510(k) Report

Devices descending from K042602

8 later devices reach Revolution XR/D Digital Radiographic Imaging System with Manual Image Pasting through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050704Modification to: Revolution XR/D Digital Radiographic Imaging System with Image Pasting…General Electric Co.200572
+2K143270Optima XR646Ge Hualun Medical Systems Co., Ltd.20156—
+3K172869Discovery XR656 HDGe Hualun Medical Systems Co., Ltd.201751
+4K231892Definium Pace SelectGe Hualun Medical Systems Co., Ltd.202311
+4K191699Discovery XR656 HD with VolumeRadGe Hualun Medical Systems Co., Ltd.201913
+4K173612Optima XR646 HDGe Hualun Medical Systems Co., Ltd.201701
+5K250788Definium Tempo SelectGe Hualun Medical Systems Co., Ltd.20250—
+5K242678Definium Pace Select ETGe Hualun Medical Systems Co., Ltd.20240—