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Software, Version 1.1, iDMS™ Data Management System
The iDMS™ Data Management System is indicated for the storage, retrieval, and processing of data utilized in the practice of radiotherapy, stereotactic radiotherapy and stereotactic radiosurgery.
ACCURAY INCORPORATED
1057208
In Commercial Distribution
- M65810572080 ()
NA
- Linear accelerator system
CyberKnife® M6™ Series (including configurations: M6 Neuro, M6 FI, M6 FIM, & M6 FM)
The CyberKnife M6 Systems are computer-controlled medical systems for planning and performing minimally invasive stereotactic radiosurgery and precision radiotherapy. They use a 6 MV linear accelerator mounted on a manipulator (robot) and a target locating subsystem to accurately deliver high-energy radiation (1000 MU/minute dose rate) to the treatment target. The target locating subsystem provides X-rays of the treatment area that lets the user know the position of the target.
The CyberKnife M6 Systems use skull tracking, fiducial tracking (tracking of implanted radiographic markers), skeletal structure tracking, lung tumor tracking, Lung Optimized Treatment, and Synchrony Respiratory Tracking for dynamic positioning and pointing of the linear accelerator. The fixed, variable aperture and multileaf collimators are available as various beam-limiting secondary collimators.
Accuray Incorporated
053101-M-000
In Commercial Distribution
- M6580531010 ()
NA
- Linear accelerator system
The CyberKnife VSI System is a computer controlled medical systems for planning and performing minimally invasive stereotactic radiosurgery and precision radiotherapy using a treatment radiation generator, linear accelerator, manipulator (robot), and a target locating subsystem to accurately deliver radiation to the treatment target. The target locating system provides X-rays of the treatment area taken by a diagnostic X-ray system that lets the user know the position of the target. The CyberKnife VSI Systems use skull tracking, fiducial tracking, Xsight® Spine Tracking, Xsight® Lung Tracking, and Synchrony® Respiratory Tracking for dynamic positioning and pointing of the linear accelerator. The system uses a 6 MV linear accelerator to provide a dose rate up to 1000 MU/minute.
ACCURAY INCORPORATED
033000-000
In Commercial Distribution
- M6580330000 ()
NA
- Linear accelerator system
The CyberKnife VSI System is a computer controlled medical systems for planning and performing minimally invasive stereotactic radiosurgery and precision radiotherapy using a treatment radiation generator, linear accelerator, manipulator (robot), and a target locating subsystem to accurately deliver radiation to the treatment target. The target locating system provides X-rays of the treatment area taken by a diagnostic X-ray system that lets the user know the position of the target. The CyberKnife VSI Systems use skull tracking, fiducial tracking, Xsight® Spine Tracking, Xsight® Lung Tracking, and Synchrony® Respiratory Tracking for dynamic positioning and pointing of the linear accelerator. The system uses a 6 MV linear accelerator to provide a dose rate up to 1000 MU/minute.
ACCURAY INCORPORATED
032500-M-000
In Commercial Distribution
- M6580325000 ()
NA
- Linear accelerator system
The Odyssey Workstation is an optional display and user interface package designed to consolidate the point of control in the Catheter Lab
Stereotaxis, Inc.
Quad HD
In Commercial Distribution
- M58800100701020 ()
001-007010-2
- Medical image management system
MoMe® Kardia is a wireless, remote monitoring system designed to aid physicians in their diagnosis of cardiac arrhythmias in patients with a demonstrated need for cardiac monitoring. MoMe® Kardia includes the wearable device that acquires and stores ECG data and transmits that data via cellular technology to the MoMe® Software Platform, a web-based remote server software with proprietary algorithms for analysis. MoMe® Software Platform analyzes the data via the embedded algorithm and when indicated, data identified by the algorithm is flagged for physician review.
Infobionic, Inc.
01854
In Commercial Distribution
- B690MK10 ()
- Electrocardiography telemetric monitoring system transmitter
No Description
BIOTRICITY INC
1.0
In Commercial Distribution
- B635BIOTRES100 ()
- Electrocardiography telemetric monitoring system transmitter
No Description
BIOTRICITY INC
1.0
In Commercial Distribution
- B635BIOFLUX1A0 ()
- Electrocardiography telemetric monitoring system transmitter
No Description
BIOTRICITY INC
1.0
In Commercial Distribution
- B635BIOFLUX101 ()
- B635BIOFLUX100 ()
- B635BIOFLUX105 ()
- B635BIOFLUX104 ()
- B635BIOFLUX103 ()
- B635BIOFLUX102 ()
- Electrocardiography telemetric monitoring system transmitter
No Description
MEDIBLU MEDICAL LLC
FM10
In Commercial Distribution
- B632MDB01007 ()
MDB01007
- Multiple vital physiological parameter monitoring system, clinical