510(k) Report

Devices descending from K982862

463 later devices reach Radworks Medical Imaging Software with Quality Control Module through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K253689syngo Dynamics (VA41F)Siemens Healthcare GmbH20260—
+10K252103Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20251—
+10K243680Neurovascular Insight V1.0Olea Medical S.A.S.20250—
+10K251747VEA Align; spineEOSEos Imaging20251—
+10K251629UNiD™ Spine AnalyzerMedicrea International S.A.S. (Medtronic)20251—
+10K251096PeekMed webPeek Health, S.A.20253—
+10K251766TumorSight VizSimBioSys, Inc.20250—
+10K241975Serv Medical CDSSServ Medical Pte., Ltd.20250—
+10K242123Brainomix 360 e-CTABrainomix Limited20250—
+10K243447Rapid Surgical Plan (RSP-SW-001)Navbit Pty, Ltd.20240—
+10K242272CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20241—
+10K230985Planmeca VisoPlanmeca Oy20233—
+10K231570StrokeViewer PerfusionNico-Lab B.V.20230—
+10K231577MOBILETT ImpactSiemens Medical Solutions20230—
+10K230016Cercare Medical NeurosuiteCercare Medical A/S20232—
+10K213986CerebralGo PlusYukun (Beijing) Technology Co., Ltd.20230—
+10K230294CoverScan (CoverScan v1.1)Perspectum20230—
+10K213165RapidIschemaview, Inc.20227—
+10K201573Brain Perfusion (BP) applicationPhilips Medical Systems Nederland B.V.20210—
+10K202350SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20210—
+10K202353SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)20202—
+10K201948AcroDTI VisualizerAcroviz, Inc.20200—
+10K200935Mazor XMazor Robotics, Ltd.202015—
+10K201058Accuvue+Radmedix, LLC20204—
+11K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.20260—
+11K253058Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd.20260—
+11K260322Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20260—
+11K261289UNiD™ Spine Analyzer (SW3002)Medicrea International S.A.S. (Medtronic)20260—
+11K252856PeekMed webPeek Health, S.A.20251—
+11K251078AutoDensityEos Imaging20250—
+11K251842Dental Computed Tomography X-ray SystemFussen Technology Co., Ltd.20251—
+11K252452PeekMed webPeek Health, S.A.20250—
+11K252526Rapid DeltaFuseIschemaview, Inc.20250—
+11K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20250—
+11K240841Digital Radiography System (ManntiX B, ManntiX K)Shenzhen Browiner Tech Co., Ltd.20240—
+11K241989Cercare Medical Neurosuite (CMN) Capillary Function with Virtual ExpertCercare Medical A/S20241—
+11K233582RapidIschemaview, Inc.20243—
+11K233512Rapid (6.0)Ischemaview, Inc.20241—
+11K210919AcuityDReRadmedix, LLC20213—
+11K203005Mazor XMazor Robotics, Ltd.2020141
+12K263033Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000…Fussen Technology Co., Ltd.20260—
+12K261368Rapid Platform (R6.7)Ischemaview, Inc.20260—
+12K261641Lower Limb AI (LLAI)AI Planning Logic, Inc.20260—
+12K253831CMN Capillary Function with Virtual Expert for MRI, CT and CBCTCercare Medical A/S20260—
+12K243350Rapid Neuro3DIschemaview, Inc.20251—
+12K231709AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4Radmedix, LLC20230—
+12K230064Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd.202332
+12K214030Universal DR 1748Konica Minolta Healthcare Americas, Inc.20221—
+12K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+13K252996Universal 1417PIKonica Minolta Healthcare Americas, Inc.20260—
+13K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+13K251987Rapid Aortic MeasurementsIschemaview, Inc.20250—
+13K251316Mazor X System / Mazor X Stealth EditionMazor Robotics, Ltd.20251—
+13K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+13K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+13K230716Robotic Graft Delivery InstrumentsMedtronic Sofamor Danek, Inc.20230—
+14K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+14K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+14K253381Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical applicationMedtronic Navigation, Inc.20260—
+14K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+14K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+15K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+15K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—