510(k) Report

Devices descending from K140334

40 later devices reach Xgeo GC80 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150165GC85ASamsung Electronics Co., Ltd.201536—
+1K143029Digital Diagnostic X-ray System (GC80)Samsung Electronics Co., Ltd.201501
+1K142492GM60A-32S, GM60A-40SSamsung Electronics Co., Ltd.2014251
+2K18234814HK701G-WLg Electronics.Inc20187—
+2K18033217HK700G-WLg Electronics20188—
+2K160997GC85ASamsung Electronics Co., Ltd.201626—
+2K150097GM60A-32S & GM60A-40SSamsung Electronics Co., Ltd.2015242
+3K22146110HQ701G-BLg Electronics.Inc20220—
+3K22139414HQ701G-BLg Electronics.Inc20221—
+3K22143417HQ701G-BLg Electronics.Inc20220—
+3K18328617HK701G-WLg Electronics.Inc20182—
+3K172229GC85ASamsung Electronics Co., Ltd.201721—
+3K163115GC70Samsung Electronics Co., Ltd.201623—
+3K162278Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd.201623—
+4K22354614HQ721G-BLg Electronics.Inc20230—
+4K21404414HQ901G-BLg Electronics.Inc20221—
+4K181629GC85ASamsung Electronics Co., Ltd.20185—
+4K180543GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85Samsung Electronics Co., Ltd.201818—
+4K171119GM85Samsung Electronics Co., Ltd.2017221
+5K260481GC85ASamsung Electronics Co., Ltd.20260—
+5K242478GF85 (models GF85-3P, GF85-SP)Samsung Electronics Co., Ltd.20240—
+5K22055917HQ901G-BLg Electronics.Inc20220—
+5K182183GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85ASamsung Electronics Co., Ltd.20180—
+5K182647GC70Samsung Electronics Co., Ltd.20180—
+5K182622GU60A, GU60A-65Samsung Electronics Co., Ltd.20180—
+5K181631GR40CWSamsung Electronics Co., Ltd.20185—
+5K181626Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd.201810—
+5K173828GU60A & GU60A-65Samsung Electronics Co., Ltd.201819—
+6K220175GM85Samsung Electronics Co., Ltd.20223—
+6K203188ADDH&abyz Co., Ltd.20213—
+6K183292Topaz Mobile DR SystemDRGEM Corporation20194—
+7K222353GM85Samsung Electronics Co., Ltd.202223
+7K213497ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)H&abyz Co., Ltd.20212—
+7K201124TOPAZ Mobile DR SystemDRGEM Corporation20203—
+8K242015TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)DRGEM Corporation20242—
+8K242651GM85Samsung Electronics Co., Ltd.20240—
+8K223930A1417MCW/A1717MCW/F1417MCWH&abyz Co., Ltd.20231—
+9K260085RAYMO Mobile X-ray System (Model: RAYMO)DRGEM Corporation20260—
+9K251443PROMODRGEM Corporation20250—
+9K241346IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)Aspen Imaging Healthcare, Inc.20240—