510(k) Report

Devices descending from K060433

136 later devices reach Digital Radiography Cxdi-50C through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K172784DX-D Imaging PackageAgfa Healthcare N.V.20170—
+7K163624Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the…Fujifilm Medical Systems U.S.A, Inc.20170—
+7K171137Evs 2430W, Evs 2430GWDRTECH Corporation20170—
+7K170451FDX Console (DR-ID300CL) SoftwareFujifilm Medical Systems U.S.A, Inc.20170—
+7K163115GC70Samsung Electronics Co., Ltd.201623—
+7K162278Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd.201623—
+8K242770Expd 114; Expd 114G; Expd 114P; Expd 114PGDRTECH Corporation20250—
+8K243443Expd 4343N1; Expd 4343N; Expd 4343U1; Expd 4343NU; Expd 4343NP; Expd 3643N1; Expd 3643N…DRTECH Corporation20250—
+8K232082EXPD 4343SDRTECH Corporation20240—
+8K231959Expd 4357; Expd 4357PDRTECH Corporation20230—
+8K230175Digital Radiography CXDI-CS01Canon, Inc.20230—
+8K222855Digital Radiography CXDI-Pro, Digital Radiography D1Canon, Inc.20220—
+8K210988Yushan X-Ray Flat Panel Detector with DROCInnocare Optoelectronics Corp.20215—
+8K181629GC85ASamsung Electronics Co., Ltd.20185—
+8K180543GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85Samsung Electronics Co., Ltd.201818—
+8K171119GM85Samsung Electronics Co., Ltd.2017221
+9K260481GC85ASamsung Electronics Co., Ltd.20260—
+9K242478GF85 (models GF85-3P, GF85-SP)Samsung Electronics Co., Ltd.20240—
+9K182183GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85ASamsung Electronics Co., Ltd.20180—
+9K182647GC70Samsung Electronics Co., Ltd.20180—
+9K182622GU60A, GU60A-65Samsung Electronics Co., Ltd.20180—
+9K181631GR40CWSamsung Electronics Co., Ltd.20185—
+9K181626Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd.201810—
+9K173828GU60A & GU60A-65Samsung Electronics Co., Ltd.201819—
+10K220175GM85Samsung Electronics Co., Ltd.20223—
+10K203188ADDH&abyz Co., Ltd.20213—
+10K183292Topaz Mobile DR SystemDRGEM Corporation20194—
+11K222353GM85Samsung Electronics Co., Ltd.202223
+11K213497ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)H&abyz Co., Ltd.20212—
+11K201124TOPAZ Mobile DR SystemDRGEM Corporation20203—
+12K242015TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)DRGEM Corporation20242—
+12K242651GM85Samsung Electronics Co., Ltd.20240—
+12K223930A1417MCW/A1717MCW/F1417MCWH&abyz Co., Ltd.20231—
+13K260085RAYMO Mobile X-ray System (Model: RAYMO)DRGEM Corporation20260—
+13K251443PROMODRGEM Corporation20250—
+13K241346IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)Aspen Imaging Healthcare, Inc.20240—