510(k) Report

Devices descending from K012211

333 later devices reach Efilm Workstation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K251842Dental Computed Tomography X-ray SystemFussen Technology Co., Ltd.20251—
+10K252452PeekMed webPeek Health, S.A.20250—
+10K252526Rapid DeltaFuseIschemaview, Inc.20250—
+10K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20250—
+10K240841Digital Radiography System (ManntiX B, ManntiX K)Shenzhen Browiner Tech Co., Ltd.20240—
+10K241989Cercare Medical Neurosuite (CMN) Capillary Function with Virtual ExpertCercare Medical A/S20241—
+10K233582RapidIschemaview, Inc.20243—
+10K233512Rapid (6.0)Ischemaview, Inc.20241—
+10K210919AcuityDReRadmedix, LLC20213—
+10K203005Mazor XMazor Robotics, Ltd.2020141
+11K263033Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000…Fussen Technology Co., Ltd.20260—
+11K261368Rapid Platform (R6.7)Ischemaview, Inc.20260—
+11K261641Lower Limb AI (LLAI)AI Planning Logic, Inc.20260—
+11K253831CMN Capillary Function with Virtual Expert for MRI, CT and CBCTCercare Medical A/S20260—
+11K243350Rapid Neuro3DIschemaview, Inc.20251—
+11K231709AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4Radmedix, LLC20230—
+11K230064Mazor X System (Mazor X Stealth Edition)Mazor Robotics, Ltd.202332
+11K214030Universal DR 1748Konica Minolta Healthcare Americas, Inc.20221—
+11K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+12K252996Universal 1417PIKonica Minolta Healthcare Americas, Inc.20260—
+12K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+12K251987Rapid Aortic MeasurementsIschemaview, Inc.20250—
+12K251316Mazor X System / Mazor X Stealth EditionMazor Robotics, Ltd.20251—
+12K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+12K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+12K230716Robotic Graft Delivery InstrumentsMedtronic Sofamor Danek, Inc.20230—
+13K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+13K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+13K253381Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical applicationMedtronic Navigation, Inc.20260—
+13K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+13K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+14K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+14K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—