510(k) Report

Devices descending from K112052

30 later devices reach Carefusion Nicolet Edx through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171781eVox SystemEvoke Neuroscience, Inc.20176—
+1K162383Cadwell Sierra Summit, Cadwell Sierra AscentCadwell Industries, Inc.201712—
+1K141316Cognision Eeg/EP SystemNeuronetrix Solutions20157—
+1K120979Carefusion Nicolet EdxCarefusion 209, Inc.201212—
+2K243982Nicolet EDXNatus Neurology Incorporated20250—
+2K243495Natus Ultrapro S100 (982A0594)Natus Neurology Incorporated20241—
+2K240420NeuroField Analysis SuiteNeurofield, Inc.20240—
+2K213900WAVi SCAN EEG System and AccessoriesWavi Co.20220—
+2K192753NeuralScan SystemMedeia, Inc.20203—
+2K182542The EPAD 2 SystemSafeop Surgical, Inc.20199—
+2K172743Natus VikingQuestNatus Neurology Incorporated20170—
+2K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.201773
+2K130346Synergy Focus Desktop Version; Synergy Focus Laptop VersionNatus Neurology Incorporated20133—
+3K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+3K253767UB ERP SystemUniversal Brain20260—
+3K221959Q21Neurofield, Inc.20230—
+3K230415Cadwell GuardianCadwell Industries, Inc.20230—
+3K221963Cumulus Functional Neurophysiology PlatformCumulus Neuroscience Limited20231—
+3K213849SafeOp 2: Neural Informatix SystemAlphatec Spine, Inc.20224—
+3K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20225—
+3K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20193—
+3K181466Cadwell Zenith SystemCadwell Industries, Inc.20180—
+4K234092SafeOp 3: Neural Informatix SysteemAlphatec Spine, Inc.20243—
+4K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20231—
+4K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+4K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20192—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+5K252842SafeOp 3: Neural Informatix SystemAlphatec Spine, Inc.202601
+5K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+6K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—