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myLUX™ Mobile Device
For use with Insertable Cardiac Monitor system
Details
Device typeImplantable cardiac device management application software: An application software program intended to be used in the management of an implantable cardiac device (e.g., monitor, pulse generator, pacemaker, defibrillator) by enabling computer-assisted functionality typically in one or more of the following areas: device programming; device function analysis; data extraction, storage, analysis and/or transfer; and clinical consultation/intervention planning. Depending on the functionality, it can run on dedicated hardware, an off-the-shelf computer (e.g., tablet, smartphone), or web-based servers.
FDA categoryRecorder, event, implantable cardiac, (with arrhythmia detection)
Device ID00802526621000
Catalog number667259-100
AvailabilityPrescription
MRI safetyMR Unsafe