510(k) Report

Devices descending from K911739

6 later devices reach Swemac Reison Biplanar 300 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131423G-Arm Multiscan SystemBeijing East Whale Imaging Technology Co., Ltd.20135—
+2K151280MultiScan G-Arm SystemBeijing East Whale Imaging Technology Co., Ltd.20153—
+2K141672Digiarc 100AU+Beijing East Whale Imaging Technology Co., Ltd.20144—
+3K251004Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)Hefei Chimed Intelligent Machine Co., Ltd.20250—
+3K160984MultiScan G-Arm SystemBeijing East Whale Imaging Technology Co., Ltd.20161—
+4K163429B6Beijing East Whale Imaging Technology Co., Ltd.20170—