510(k) Report

Devices descending from K092363

34 later devices reach Softview, Model 2.01 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161201ClearRead CTRiverain Technologies, LLC20165—
+1K133442Bone Suppression SoftwareCarestream Health, Inc.20140—
+1K123526Clearread +ConfirmRiverain Technologies201225—
+1K111776Deltaview Model 2.1Riverain Medical Group,Llc20110—
+2K254075Synapse Lung Nodule AIFujifilm Corporation20260—
+2K242919V5med Lung AIV5med, Inc.20250—
+2K221612ClearRead CTRiverain Technologies, Inc.20220—
+2K212690qXR-BTQure.Ai Technologies20210—
+2K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+2K162278Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd.201623—
+3K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+3K171119GM85Samsung Electronics Co., Ltd.2017221
+4K181629GC85ASamsung Electronics Co., Ltd.20185—
+4K181631GR40CWSamsung Electronics Co., Ltd.20185—
+4K180543GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85Samsung Electronics Co., Ltd.201818—
+4K173828GU60A & GU60A-65Samsung Electronics Co., Ltd.201819—
+5K260481GC85ASamsung Electronics Co., Ltd.20260—
+5K242478GF85 (models GF85-3P, GF85-SP)Samsung Electronics Co., Ltd.20240—
+5K203188ADDH&abyz Co., Ltd.20213—
+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—
+5K181626Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd.201810—
+6K220175GM85Samsung Electronics Co., Ltd.20223—
+6K213497ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)H&abyz Co., Ltd.20212—
+6K183292Topaz Mobile DR SystemDRGEM Corporation20194—
+7K223930A1417MCW/A1717MCW/F1417MCWH&abyz Co., Ltd.20231—
+7K222353GM85Samsung Electronics Co., Ltd.202223
+7K201124TOPAZ Mobile DR SystemDRGEM Corporation20203—
+8K242015TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)DRGEM Corporation20242—
+8K241346IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)Aspen Imaging Healthcare, Inc.20240—
+8K242651GM85Samsung Electronics Co., Ltd.20240—
+9K260085RAYMO Mobile X-ray System (Model: RAYMO)DRGEM Corporation20260—
+9K251443PROMODRGEM Corporation20250—