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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
1047641-000
In Commercial Distribution
- M65810476410 ()
NA
- Linear accelerator system
The TomoTherapy Treatment Delivery System with iDMS is indicated for the delivery of radiation therapy, stereotactic radiotherapy or
stereotactic radiosurgery to tumors or other targeted tissues anywhere in the body under the direction of a licensed medical practitioner.
ACCURAY INCORPORATED
1068286
In Commercial Distribution
- M65810682860 ()
NA
- Linear accelerator system
The TomoTherapy Treatment Delivery System with iDMS is indicated for the delivery of radiation therapy, stereotactic radiotherapy or
stereotactic radiosurgery to tumors or other targeted tissues anywhere in the body under the direction of a licensed medical practitioner.
ACCURAY INCORPORATED
1068284
In Commercial Distribution
- M65810682840 ()
NA
- Linear accelerator system
The TomoTherapy Treatment Delivery System with iDMS is indicated for the delivery of radiation therapy, stereotactic radiotherapy or
stereotactic radiosurgery to tumors or other targeted tissues anywhere in the body under the direction of a licensed medical practitioner.
ACCURAY INCORPORATED
1068283
In Commercial Distribution
- M65810682830 ()
NA
- Linear accelerator system
Software, iDMS™ Data Management System, (Version 1.1.1.1)
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
1062409
In Commercial Distribution
- M65810624090 ()
NA
- Linear accelerator system
TomoTherapy Treatment Delivery System with iDMS, Version 1.1
ACCURAY INCORPORATED
1062071
In Commercial Distribution
- M65810620710 ()
NA
- Linear accelerator system
Magnetoencephalography system (MEG), 275 channel
CTF MEG International Services Limited Partnership
CTF MEG 275
In Commercial Distribution
- B956CO0275110 ()
CO-0275-1-1
- Magnetoencephalography system, superconducting
Bolt Navigation Case
Circinus Medical Technology LLC
BN002-02
In Commercial Distribution
- BN981BN002023 ()
BN002-02
- Surgical planning/navigation-enhancement system
Bolt Navigation Unit, Gen 2.0
Circinus Medical Technology LLC
BN001-02
In Commercial Distribution
- BN981BN001021 ()
BN001-02
- Surgical planning/navigation-enhancement system
The capsule is a physiologic battery-powered device used for gastric monitoring and data collection. The tethered pH capsule is swallowed by the patient. The information gathered by the capsule contains one or more gastric parameters (i.e., pH, events and or gastric bleeding, delayed stomach emptying, or gastric dumping). The capsule is comprised of a sensor for monitoring gastric pH and movement. The telemetric signals produced by the pH capsule are detected by the patient worn transceiver. The capsules data is transmitted from the transceiver to the Heidelberg Interface module. The interface module sends the capsule information to the computer. The computer software interprets the capsule data and displays it on computer generated graph. This is a single-use device.
Heidelberg Medical Inc
Heidelberg pH Telemetric Capsules
In Commercial Distribution
- B989HTC1020 ()
HTC102
- Gastrointestinal telemetric monitoring system capsule, ingestible