510(k) Report

Devices descending from K013878

140 later devices reach Cybermed, Inc., V-Works through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K230685AutoContour Model RADAC V3Radformation, Inc.20235—
+7K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+7K213562DTX Studio Clinic 3.0Nobel Biocare AB20229—
+7K210632Contour ProtegeAIMim Software, Inc.20215—
+7K192038Emprint Visualization ApplicationCovidien, LLC20191—
+7K163539Ez3D-i / E3Ewoosoft Co., Ltd.20161—
+7K151233MonacoImpac Medical Systems, Inc.201569
+8K252947HistoSonics® Planning ToolHistoSonics, Inc.20260—
+8K242994OncoStudio (OS-01)Oncosoft. Co., Ltd.20251—
+8K242729AutoContour (Model RADAC V4)Radformation, Inc.20242—
+8K233925Relu CreatorRelu BV20246—
+8K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+8K232479ART-PlanTherapanacea20232—
+8K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+8K213976Contour ProtégéAIMim Software, Inc.20224—
+8K183037Monaco RTP SystemElekta, Inc.201856
+8K173863Ez3D-i /E3Ewoosoft Co., Ltd.20180—
+9K260528OncoStudioOncosoft. Inc.,20260—
+9K253078ART.1-USSeetreat Pty, Ltd.20260—
+9K260785DS Core CBCT AnatomyDentsply Sirona20261—
+9K260509AutoContour (RADAC V5)Radformation, Inc.20261—
+9K252538CEPHX3DOrca Dental AI, Ltd.20260—
+9K243989Second Opinion® 3DPearl, Inc.20253—
+9K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+9K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+9K234068ART-Plan (v.2.2.0)Therapanacea Sas20240—
+9K223774Contour ProtégéAIMim Software, Inc.20233—
+9K190178Monaco RTP SystemElekta, Inc.201945
+10K262127DS Core CBCT AnatomyDentsply Sirona20260—
+10K262452AutoContour (RADAC V6)Radformation, Inc.20260—
+10K254096VELMENI for DENTISTS (V4D) 3DVelmeni, Inc.20260—
+10K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation20260—
+10K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—
+10K231765Contour ProtégéAIMim Software, Inc.20232—
+10K202789Monaco Rtp SystemElekta Solutions AB20213—
+11K250035Contour ProtégéAI+Mim Software, Inc.20251—
+11K213787Monaco RTP SystemElekta Solutions AB20222—
+12K253270Contour ProtégéAI+Mim Software, Inc.20260—
+12K223233Monaco RTP SystemElekta Solutions AB20231—
+13K252002Monaco RTP System (6.3)Elekta Solutions AB20260—