510(k) Report

Devices descending from K143270

6 later devices reach Optima XR646 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172869Discovery XR656 HDGe Hualun Medical Systems Co., Ltd.201751
+2K231892Definium Pace SelectGe Hualun Medical Systems Co., Ltd.202311
+2K191699Discovery XR656 HD with VolumeRadGe Hualun Medical Systems Co., Ltd.201913
+2K173612Optima XR646 HDGe Hualun Medical Systems Co., Ltd.201701
+3K250788Definium Tempo SelectGe Hualun Medical Systems Co., Ltd.20250—
+3K242678Definium Pace Select ETGe Hualun Medical Systems Co., Ltd.20240—