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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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Accuray Precision® Treatment Planning System - M65810598110

Software, Version 1.1.1, Accuray Precision Treatment Planning System The Accuray Precision Treatment Planning System is a radiation therapy planning system used for creation and assessment of treatment plans for delivery by radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery treatment systems.
ACCURAY INCORPORATED
1059811
In Commercial Distribution

  • M65810598110 ()
NA

  • Radiation therapy treatment planning computer
  • Linear accelerator system

Accuray Precision® Treatment Planning System - M65810550960

Software, Version 1.0.0.1, Accuray Precision Treatment Planning System, The Accuray Precision Treatment Planning System is a radiation therapy planning system used for creation and assessment of treatment plans for delivery by radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery treatment systems.
ACCURAY INCORPORATED
1055096
In Commercial Distribution

  • M65810550960 ()
NA

  • Linear accelerator system
  • Radiation therapy treatment planning computer

Accuray Precision® Treatment Planning System - M65810502420

Software, Version 1.0, Precision Treatment Planning System The Accuray Precision Treatment Planning System is indicated for creation and assessment of external photon beam irradiation treatment plans for radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. A treatment plan provides an estimate of the dose distribution and the parameters utilized by the radiation delivery system. Plans must be reviewed and approved by qualified medical practitioners prior to delivery.
ACCURAY INCORPORATED
1050242
In Commercial Distribution

  • M65810502420 ()
NA

  • Linear accelerator system
  • Radiation therapy treatment planning computer

Cardiodrive System - M588001004115120

The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System (MNS). It is not intended to advance the EP mapping and ablation catheters through the coronary vasculature nor the coronary sinus.
Stereotaxis, Inc.
II
In Commercial Distribution

  • M588001004115120 ()
001-004115-12

  • Robotic surgical navigation system

Genesis MNS with Model-S - M58800101100030

"Genesis MNS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart and coronary vasculature, neurovascular and peripheral vasculature by orienting the device tip in a desired direction. "
Stereotaxis, Inc.
1.1 Model-S
In Commercial Distribution

  • M58800101100030 ()
001-011000-3

  • Robotic surgical navigation system

Genesis (RMNS) - M58800101100010

Genesis RMNS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart and coronary vasculature, neurovascular and peripheral vasculature by orienting the device tip in a desired direction.
Stereotaxis, Inc.
1.1
In Commercial Distribution

  • M58800101100010 ()
001-011000-1

  • Robotic surgical navigation system

Cardiodrive System - M588001004115110

The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System (MNS). It is not intended to advance the EP mapping and ablation catheters through the coronary vasculature nor the coronary sinus.
Stereotaxis, Inc.
II
In Commercial Distribution

  • M588001004115110 ()
001-004115-11

  • Robotic surgical navigation system

TMINI™ Navigation Console - M9461087570

No Description
THINK SURGICAL, INC.
108757
In Commercial Distribution

  • M9461087570 ()
108757

  • Robotic surgical navigation system

UbiqVue - B353UA2251C1

Holter Web Portal
Lifesignals, Inc.
UA2251-C
In Commercial Distribution

  • B353UA2251C1 ()


  • Wireless patient monitor/sensor reporting software, professional-only

LENS - G253LW30

NKPW Psychophysiological biofeedback system A computerized device assembly designed for analysis and real-time feedback (biofeedback) of a variety of physiological parameters [e.g., heart rate, respiration, skin conductance, skin temperature, range of motion, force output, electroencephalography (EEG), electromyography (EMG), electrocardiography (ECG) data] to assist a patient in developing a degree of conscious control over typically involuntary functions, usually for relaxation training and muscle re-education. It includes multiple pieces of patient monitoring hardware (e.g., electrodes, sensors), computer interface devices, and dedicated software; it is intended to be used with an off-the-shelf computer. HJLM Biofeedback system application software An application software program designed for use in, or together with, a biofeedback system, so that it may function according to its intended purpose. This software program can be permanently installed, or exchanged as an upgrade. It may also be produced for installation in an off-the-shelf desktop or laptop computer.
Ochs Labs LLC
LW3
In Commercial Distribution

  • G253LW30 ()


  • Biofeedback system application software
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