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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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The Eko Analysis Software is intended to provide support to the physician in the evaluation of patients' heart sounds and ECG’s. The software analyzes simultaneous ECG and heart sounds. The software will detect the presence of suspected murmurs in the heart sounds. The software also detects the presence of atrial fibrillation and normal sinus rhythm from the ECG signal. In addition, it calculates certain cardiac time intervals such as heart rate, QRS duration and EMAT. The software does not distinguish between different kinds of murmurs and does not identify other arrhythmias. It is not intended as a sole means of diagnosis. The interpretations of heart sounds and ECG offered by the software are only significant when used in conjunction with physician over-read and is for use on adults (> 18 years)
Eko Devices, Inc.
EAS
In Commercial Distribution

  • 00850010298030 ()


  • Cardiopulmonary physiological parameter analysis software
System Software for NeuroStar Mobile Console
NEURONETICS, INC.
Version 3.8
In Commercial Distribution

  • 00850005944355 ()
83-00093-000

  • Magnetic neural stimulation system
System Software for NeuroStar Mobile Console
NEURONETICS, INC.
Version 3.6
In Commercial Distribution

  • 00850005944119 ()
83-00054-000

  • Magnetic neural stimulation system
System Software for NeuroStar Mobile Console
NEURONETICS, INC.
Version 3.5
In Commercial Distribution

  • 00850005944089 ()
83-00054-000

  • Magnetic neural stimulation system
SFW KIT 9735739 STEALTH S8 STEREOTX
MEDTRONIC NAVIGATION, INC.
9735739
In Commercial Distribution

  • 00643169838987 ()


  • Neurological stereotactic surgery system
SFW KIT 9735738 STEALTH S8 CRN DBS
MEDTRONIC NAVIGATION, INC.
9735738
In Commercial Distribution

  • 00643169838970 ()


  • Neurological stereotactic surgery system
SW KIT 9735737 STEALTH S8 CRANIAL
MEDTRONIC NAVIGATION, INC.
9735737
In Commercial Distribution

  • 00643169838963 ()


  • Neurological stereotactic surgery system
No Description
KONICA MINOLTA, INC.
AEVM
In Commercial Distribution

  • 04560141951433 ()


  • Basic diagnostic x-ray system application software
MapRT is used to assist treatment planning whereby the patient surface and positioning devices captured at simulation can be modelled against the treatment devices, such that any potential collisions can be predicted.
VISION RT LIMITED
MapRT acquisition software
In Commercial Distribution

  • 05056190500757 ()
MapRT

  • Radiation therapy software
AlignRT 7.3 (software) used on AlignRT Plus systems
VISION RT LIMITED
AlignRT 7.3 (software)
In Commercial Distribution

  • 05056190500726 ()
AlignRT 7.3 (software)

  • Radiological video camera patient positioning/tracking system
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