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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
Active Monitoring Portal
Lifesignals, Inc.
UA2550-C
In Commercial Distribution
- B353UA2550C1 ()
- Wireless patient monitor/sensor reporting software, professional-only
- Wearable multiple vital physiological parameter monitor
GCX Mounting rails for front supports in PM/KM/XM carriers only (set, includes hardware) H8-010-51 GCX track sold separately
SKYTRON LLC
H8-200-01-GCX
In Commercial Distribution
- 10841736114091 ()
- General utility supply system, ceiling-mounted
Pathway® MR-25 Dual Channel EMG
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
MR-25
In Commercial Distribution
- 00852423006042 ()
9725
- Perineometer
- Psychophysiological biofeedback system
Pathway® NMR 200 Dual Channel Module
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
NMR 200
In Commercial Distribution
- 00852423006394 ()
NMR 200
- Perineometer
- Psychophysiological biofeedback system
Pathway® MR-10 Single Channel EMG
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
MR-10
In Commercial Distribution
- 00852423006073 ()
9700
- Perineometer
- Psychophysiological biofeedback system
Pathway® MR-15 Single Channel EMG
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
MR-15
In Commercial Distribution
- 00852423006066 ()
9715
- Perineometer
- Psychophysiological biofeedback system
Pathway® MR-20 Dual Channel EMG
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
MR-20
In Commercial Distribution
- 00852423006059 ()
9710
- Perineometer
- Psychophysiological biofeedback system
Element intended to become part of an assembly of non-sterile devices designed to stabilize fractured bones to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device intended to be sterilized prior to use.
GEXFIX SA
1010-1010
In Commercial Distribution
- 07640136270019 ()
- External orthopaedic fixation system, single-use
The Vios Monitoring System (VMS) Adapter and Chest Sensor are intended for use by medically qualified personnel for physiological vital signs monitoring of adult (18+) patients in healthcare facilities. It is indicated for use in monitoring of 7-Lead ECG, heart rate, respiratory rate, pulse rate, functional oxygen saturation of arterial hemoglobin, non-invasive blood pressure (NIBP) continuously and patient posture and activity. VMS allows for the input of body temperature and can display data from peripheral devices. VMS can generate alerts when rate-based cardiac arrhythmias are detected and when physiological vital signs fall outside of selected parameters.
The non-invasive blood pressure tracking is based on Pulse Arrival Time (PAT) which is obtained utilizing ECG and PPG signals, following a calibration process using an FDA-cleared oscillometric blood pressure monitor. This feature is not intended for use in critical care environment.
VMS can also generate alerts when cardiac arrhythmias (Tachycardia, Bradycardia, Asystole, Ventricular Tachycardia/Ventricular Fibrillation and Atrial Fibrillation/Atrial Flutter) are detected.
The ECG rhythm analysis is intended for use by medically qualified professionals in the identification of arrhythmia events and to aid in clinical review of arrhythmia and medical interventions.
The VMS Adapter and Chest Sensor are intended to be used by Vios-trained clinical professionals who also have a working knowledge of medical procedures, practices, and terminology, as required for monitoring patients.
MURATA VIOS, INC.
L2050G Adapter
In Commercial Distribution
- B595L2050G0 ()
L2050G
- Cardiac arrhythmia monitoring system
- Wearable multiple vital physiological parameter monitoring system