510(k) Report

Devices descending from K013481

45 later devices reach Dual Energy and Tissue Equalization Software Option through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190330DRX-Evolution/Plus with Dual EnergyCarestream Health, Inc.20192—
+1K122454Fujifilm Dual Energy Subtraction (Des) Software OptionFujifilm Medical System U.S.A., Inc.20126—
+1K092363Softview, Model 2.01Riverain Medical Group201034—
+2K233381DRX-Evolution Plus SystemCarestream Health, Inc.20241—
+2K161201ClearRead CTRiverain Technologies, LLC20165—
+2K152294FDR Visionary SuiteShimadzu Corporation201615
+2K152244RADspeed ProShimadzu Corporation201632
+2K133442Bone Suppression SoftwareCarestream Health, Inc.20140—
+2K123526Clearread +ConfirmRiverain Technologies201225—
+2K111776Deltaview Model 2.1Riverain Medical Group,Llc20110—
+3K254075Synapse Lung Nodule AIFujifilm Corporation20260—
+3K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector…Carestream Health20260—
+3K242919V5med Lung AIV5med, Inc.20250—
+3K233719FDR Visionary SuiteShimadzu Corporation20240—
+3K233722RADspeed ProShimadzu Corporation202401
+3K221612ClearRead CTRiverain Technologies, Inc.20220—
+3K212690qXR-BTQure.Ai Technologies20210—
+3K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+3K173517RADspeed fitShimadzu Corporation20181—
+3K162278Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd.201623—
+4K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+4K220518Skanrad 400Skanray Technologies Limited20220—
+4K171119GM85Samsung Electronics Co., Ltd.2017221
+5K181629GC85ASamsung Electronics Co., Ltd.20185—
+5K181631GR40CWSamsung Electronics Co., Ltd.20185—
+5K180543GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85Samsung Electronics Co., Ltd.201818—
+5K173828GU60A & GU60A-65Samsung Electronics Co., Ltd.201819—
+6K260481GC85ASamsung Electronics Co., Ltd.20260—
+6K242478GF85 (models GF85-3P, GF85-SP)Samsung Electronics Co., Ltd.20240—
+6K203188ADDH&abyz Co., Ltd.20213—
+6K182183GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85ASamsung Electronics Co., Ltd.20180—
+6K182647GC70Samsung Electronics Co., Ltd.20180—
+6K182622GU60A, GU60A-65Samsung Electronics Co., Ltd.20180—
+6K181626Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd.201810—
+7K220175GM85Samsung Electronics Co., Ltd.20223—
+7K213497ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)H&abyz Co., Ltd.20212—
+7K183292Topaz Mobile DR SystemDRGEM Corporation20194—
+8K223930A1417MCW/A1717MCW/F1417MCWH&abyz Co., Ltd.20231—
+8K222353GM85Samsung Electronics Co., Ltd.202223
+8K201124TOPAZ Mobile DR SystemDRGEM Corporation20203—
+9K242015TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)DRGEM Corporation20242—
+9K241346IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)Aspen Imaging Healthcare, Inc.20240—
+9K242651GM85Samsung Electronics Co., Ltd.20240—
+10K260085RAYMO Mobile X-ray System (Model: RAYMO)DRGEM Corporation20260—
+10K251443PROMODRGEM Corporation20250—