The TargetScan needles are used in conjunction with the biopsy planning feature
The TargetScan needles are used in conjunction with the biopsy planning feature of Targetscan to target the prostate biopsy locations created in a biopsy plan.
The Disposable Template, when used in conjunction with a reusable frame, is used
The Disposable Template, when used in conjunction with a reusable frame, is used for assisting the physician in placement of the brachytherapy needles for prostate brachytherapy procedures.
IWJ
System, Applicator, Radionuclide, Manual
1
Disposable Template, 18 Gauge, Non-Siemens, Single
The High Dose Rate Frame, when used in conjunction with a High Dose Rate Sandwic
The High Dose Rate Frame, when used in conjunction with a High Dose Rate Sandwich, is used for assisting the physician in placement of the brachytherapy needles for prostate brachytherapy procedures.
The Disposable Template, when used in conjunction with a reusable frame, is used
The Disposable Template, when used in conjunction with a reusable frame, is used for assisting the physician in placement of the brachytherapy needles for prostate brachytherapy procedures.
The Bard SurePoint Stepper Reusable Frame, when used in conjunction with a dispo
The Bard SurePoint Stepper Reusable Frame, when used in conjunction with a disposable template, is used for assisting the physician in placement of the brachytherapy needles for prostate brachytherapy procedures.
The Sonalis Cradle is device which is used to hold an ultrasound rectal probe du
The Sonalis Cradle is device which is used to hold an ultrasound rectal probe during prostate therapy. The Sonalis Cradle is used primarily in conjunction with the Best Precision Stepper but is also able to be used with other manufacturer’s steppers.
The Precision Stepper is designed to hold and manipulate an ultrasound rectal pr
The Precision Stepper is designed to hold and manipulate an ultrasound rectal probe during prostate therapy. The Precision Stepper is used for assisting the physician in placement of the Ultrasound Transducer and Brachytherapy needles for prostate brachytherapy procedures. The Precision Stepper is intended to be mounted onto a stabilizing device such as the Best Precision Stabilizer
Parts of the internal anatomy move relative to external or bony landmarks. The B
Parts of the internal anatomy move relative to external or bony landmarks. The BATCAM 7.0 MultiProbe Ultrasound Localization and Positioning System resolves this movement by permitting it’s users to locate and position the part of the internal anatomy that is being treated as accurately and correctly as possible for the delivery of conformal radiation without relying on external structures.
Parts of the internal anatomy move relative to external or bony landmarks. The B
Parts of the internal anatomy move relative to external or bony landmarks. The BATCAM 7.0 MultiProbe Ultrasound Localization and Positioning System resolves this movement by permitting it’s users to locate and position the part of the internal anatomy that is being treated as accurately and correctly as possible for the delivery of conformal radiation without relying on external structures.
CORVUS 14 is intended for use as a planning tool for conformal radiation therapy
CORVUS 14 is intended for use as a planning tool for conformal radiation therapy. The CORVUS system is intended to be used as an integrated system with a delivery device for planning and delivery of conformal radiation therapy. . For IMRT, using operator-supplied input and patient scans, it creates a plan for treatment delivery systems and generates a set of beam weights that, when applied to a compatible system, facilitates delivery of an intensity-modulated 3D conformal radiation therapy treatment. For Forward Planning, CORVUS helps the user manually create a plan for treatment delivery based on user supplied inputs and patient scans including dose calculation. Forward Planning is supported only for Cobalt-60 based treatment planning.
The TargetScan needles are used in conjunction with the biopsy planning feature
The TargetScan needles are used in conjunction with the biopsy planning feature of Targetscan to target the prostate biopsy locations created in a biopsy plan.
The Siemens Cradle is device which is used to hold an ultrasound rectal probe du
The Siemens Cradle is device which is used to hold an ultrasound rectal probe during prostate therapy. The Siemens Cradle is used primarily in conjunction with the Best Precision Stepper but is also able to be used with other manufacturer’s steppers.
The Reusable Template is used for assisting the physician in placement of the br
The Reusable Template is used for assisting the physician in placement of the brachytherapy needles for prostate brachytherapy procedures.
IWJ
System, Applicator, Radionuclide, Manual
1
Reusable Template, Best Precision Stepper, 17 Gauge, Siemens Ultrasound
The Disposable Template, when used in conjunction with a reusable frame, is used
The Disposable Template, when used in conjunction with a reusable frame, is used for assisting the physician in placement of the brachytherapy needles for prostate brachytherapy procedures.
The High Dose Rate Sandwich, when used in conjunction with a High Dose Rate Fram
The High Dose Rate Sandwich, when used in conjunction with a High Dose Rate Frame, is used for assisting the physician in placement of the brachytherapy needles for prostate brachytherapy procedures.
The CMS AccuSeed Stepper Reusable Frame, when used in conjunction with a disposa
The CMS AccuSeed Stepper Reusable Frame, when used in conjunction with a disposable template, is used for assisting the physician in placement of the brachytherapy needles for prostate brachytherapy procedures.
The Best Precision Stepper Reusable Frame, when used in conjunction with a dispo
The Best Precision Stepper Reusable Frame, when used in conjunction with a disposable template, is used for assisting the physician in placement of the brachytherapy needles for prostate brachytherapy procedures.
The TargetScan Touch® Transrectal Ultrasound System images the prostate. From t
The TargetScan Touch® Transrectal Ultrasound System images the prostate. From the image, the system can construct a biopsy or treatment plan displayed as an overlay, or target, on the ultrasound image. In conjunction with the planned locations, accessory mechanical guides are used to position biopsy and treatment devices.
The Best TPS system is a computer based software system developed the use of ass
The Best TPS system is a computer based software system developed the use of assisting in the placement of anatomical localization and low dose rate isotope implants Best TPS uses multiple two-dimensional images including ultrasound and DICOM images which are outlined by a qualified medical staff member, then reconstructed to create three dimensional structures and matrices.
The Precision Stabilizer consists of one Trigger Head and two Stabilizer Arms.Th
The Precision Stabilizer consists of one Trigger Head and two Stabilizer Arms.The Precision Stabilizer is intended to provide a platform for devices that need a support mechanism in 3D space and it allows for 6-degrees of freedom to position the device in 3D space. One of it's intended uses is to provide a platform for use of an ultrasound transducer.
The Reusable Template is used for assisting the physician in placement of the br
The Reusable Template is used for assisting the physician in placement of the brachytherapy needles for prostate brachytherapy procedures.
IWJ
System, Applicator, Radionuclide, Manual
1
Reusable Template, Best Precision Stepper, 18 Gauge, Non-Siemens Ultrasound
The Hitachi Cradle is device which is used to hold an ultrasound rectal probe du
The Hitachi Cradle is device which is used to hold an ultrasound rectal probe during prostate therapy. The Hitachi Cradle is used primarily in conjunction with the Best Precision Stepper but is also able to be used with other manufacturer’s steppers.
The Sonalis-NG Cradle is device which is used to hold an ultrasound rectal probe
The Sonalis-NG Cradle is device which is used to hold an ultrasound rectal probe during prostate therapy. The Sonalis-NG Cradle is used primarily in conjunction with the Best Precision Stepper but is also able to be used with other manufacturer’s steppers.
The Reusable Template is used for assisting the physician in placement of the br
The Reusable Template is used for assisting the physician in placement of the brachytherapy needles for prostate brachytherapy procedures.
IWJ
System, Applicator, Radionuclide, Manual
1
Reusable Template, Best Precision Stepper, 18 Gauge, Siemens Ultrasound
The Disposable Template, when used in conjunction with a reusable frame, is used
The Disposable Template, when used in conjunction with a reusable frame, is used for assisting the physician in placement of the brachytherapy needles for prostate brachytherapy procedures.
IWJ
System, Applicator, Radionuclide, Manual
1
Disposable Template, 17 Gauge, Non-Siemens, Single
The High Dose Rate Sandwich, when used in conjunction with a High Dose Rate Fram
The High Dose Rate Sandwich, when used in conjunction with a High Dose Rate Frame, is used for assisting the physician in placement of the brachytherapy needles for prostate brachytherapy procedures.
The Disposable Template, when used in conjunction with a reusable frame, is used
The Disposable Template, when used in conjunction with a reusable frame, is used for assisting the physician in placement of the brachytherapy needles for prostate brachytherapy procedures.
The Disposable Template, when used in conjunction with a reusable frame, is used
The Disposable Template, when used in conjunction with a reusable frame, is used for assisting the physician in placement of the brachytherapy needles for prostate brachytherapy procedures.
The GE ERB Cradle is device which is used to hold an ultrasound rectal probe dur
The GE ERB Cradle is device which is used to hold an ultrasound rectal probe during prostate therapy. The GE ERB Cradle is used primarily in conjunction with the Best Precision Stepper but is also able to be used with other manufacturer’s steppers.
The BK Cradle is device which is used to hold an ultrasound rectal probe during
The BK Cradle is device which is used to hold an ultrasound rectal probe during prostate therapy. The BK Cradle is used primarily in conjunction with the Best Precision Stepper but is also able to be used with other manufacturer’s steppers.
The TargetScan needles are used in conjunction with the biopsy planning feature
The TargetScan needles are used in conjunction with the biopsy planning feature of Targetscan to target the prostate biopsy locations created in a biopsy plan.
The TargetScan needles are used in conjunction with the biopsy planning feature
The TargetScan needles are used in conjunction with the biopsy planning feature of the Targetscan System to target the prostate biopsy locations created in a biopsy plan.
The High Dose Rate Frame, when used in conjunction with a High Dose Rate Sandwic
The High Dose Rate Frame, when used in conjunction with a High Dose Rate Sandwich, is used for assisting the physician in placement of the brachytherapy needles for prostate brachytherapy procedures.
The High Dose Rate Frame, when used in conjunction with a High Dose Rate Sandwic
The High Dose Rate Frame, when used in conjunction with a High Dose Rate Sandwich, is used for assisting the physician in placement of the brachytherapy needles for prostate brachytherapy procedures.
IWJ
System, Applicator, Radionuclide, Manual
1
High Dose Rate Frame, Best Precision Stepper (Siemens Grid)
The Disposable Template, when used in conjunction with a reusable frame, is used
The Disposable Template, when used in conjunction with a reusable frame, is used for assisting the physician in placement of the brachytherapy needles for prostate brachytherapy procedures.
The BK Cradle is device which is used to hold an ultrasound rectal probe during
The BK Cradle is device which is used to hold an ultrasound rectal probe during prostate therapy. The BK Cradle is used primarily in conjunction with the Best Precision Stepper but is also able to be used with other manufacturer’s steppers.
The Aloka Cradle is device which is used to hold an ultrasound rectal probe duri
The Aloka Cradle is device which is used to hold an ultrasound rectal probe during prostate therapy. The Aloka Cradle is used primarily in conjunction with the Best Precision Stepper but is also able to be used with other manufacturer’s steppers.
The Sonalis Ultrasound System is a real time, two dimensional, diagnostic ultras
The Sonalis Ultrasound System is a real time, two dimensional, diagnostic ultrasound system which produces high quality images through user friendly operation. The system currently supports imaging applications for trans-rectal ultrasound imaging.
CORVUS 09 is intended for use as a planning tool for conformal radiation therapy
CORVUS 09 is intended for use as a planning tool for conformal radiation therapy. CORVUS 09 is designed to generate plans for treatment delivery systems that can create multiple radiation patterns composed of pencil beams on which the intensity can be individually controlled. CORVUS 09 system is intended to be used as an integrated system with a modulating device for planning and delivery of conformal radiation therapy.
The High Dose Rate Frame, when used in conjunction with a High Dose Rate Sandwic
The High Dose Rate Frame, when used in conjunction with a High Dose Rate Sandwich, is used for assisting the physician in placement of the brachytherapy needles for prostate brachytherapy procedures.
The High Dose Rate Frame, when used in conjunction with a High Dose Rate Sandwic
The High Dose Rate Frame, when used in conjunction with a High Dose Rate Sandwich, is used for assisting the physician in placement of the brachytherapy needles for prostate brachytherapy procedures.
IWJ
System, Applicator, Radionuclide, Manual
1
High Dose Rate Frame, Best Precision Stepper (BK Grid)
The Civco/BW Stepper Reusable Frame, when used in conjunction with a disposable
The Civco/BW Stepper Reusable Frame, when used in conjunction with a disposable template, is used for assisting the physician in placement of the brachytherapy needles for prostate brachytherapy procedures.
The BK Cradle is device which is used to hold an ultrasound rectal probe during
The BK Cradle is device which is used to hold an ultrasound rectal probe during prostate therapy. The BK Cradle is used primarily in conjunction with the Best Precision Stepper but is also able to be used with other manufacturer’s steppers.
CORVUS 09 is intended for use as a planning tool for conformal radiation therapy
CORVUS 09 is intended for use as a planning tool for conformal radiation therapy. CORVUS 09 is designed to generate plans for treatment delivery systems that can create multiple radiation patterns composed of pencil beams on which the intensity can be individually controlled. CORVUS 09 system is intended to be used as an integrated system with a modulating device for planning and delivery of conformal radiation therapy.
CORVUS 09 is intended for use as a planning tool for conformal radiation therapy
CORVUS 09 is intended for use as a planning tool for conformal radiation therapy. CORVUS 09 is designed to generate plans for treatment delivery systems that can create multiple radiation patterns composed of pencil beams on which the intensity can be individually controlled. CORVUS 09 system is intended to be used as an integrated system with a modulating device for planning and delivery of conformal radiation therapy.
CORVUS 15 is intended for use as a planning tool for conformal radiation therapy
CORVUS 15 is intended for use as a planning tool for conformal radiation therapy. The CORVUS system is intended to be used as an integrated system with a delivery device for planning and delivery of conformal radiation therapy. . For IMRT, using operator-supplied input and patient scans, it creates a plan for treatment delivery systems and generates a set of beam weights that, when applied to a compatible system, facilitates delivery of an intensity-modulated 3D conformal radiation therapy treatment. For Forward Planning, CORVUS helps the user manually create a plan for treatment delivery based on user supplied inputs and patient scans including dose calculation. Forward Planning is supported only for Cobalt-60 based treatment planning.
The Reusable Template is used for assisting the physician in placement of the br
The Reusable Template is used for assisting the physician in placement of the brachytherapy needles for prostate brachytherapy procedures.
IWJ
System, Applicator, Radionuclide, Manual
1
Reusable Template, Best Precision Stepper, 17 Gauge, Non-Siemens Ultrasound
The Disposable Template, when used in conjunction with a reusable frame, is used
The Disposable Template, when used in conjunction with a reusable frame, is used for assisting the physician in placement of the brachytherapy needles for prostate brachytherapy procedures.
The Civco/BW Stepper Reusable Frame, when used in conjunction with a disposable
The Civco/BW Stepper Reusable Frame, when used in conjunction with a disposable template, is used for assisting the physician in placement of the brachytherapy needles for prostate brachytherapy procedures.
Software, Version 2.0, Accuray Precision Treatment Planning SystemThe Accuray Pr
Software, Version 2.0, Accuray Precision Treatment Planning SystemThe 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.
Software, TomoApps, Version 5.1.3Operating Software for TomoTherapy systems (inc
Software, TomoApps, Version 5.1.3Operating Software for TomoTherapy systems (including TomoH, TomoHD, TomoHDA) and Onrad Treatment System.
Software, Accuray Precision Treatment Planning System, (Version 1.1.1.1)The Accu
Software, Accuray Precision Treatment Planning System, (Version 1.1.1.1)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.
Software, TomoApps, Version 5.1.2Operating Software for TomoTherapy systems (inc
Software, TomoApps, Version 5.1.2Operating Software for TomoTherapy systems (including TomoH®, TomoHD®, TomoHDA) and Onrad Treatment System™
Software, Version 1.1.1, Accuray Precision Treatment Planning SystemThe Accuray
Software, Version 1.1.1, Accuray Precision Treatment Planning SystemThe 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.
Software, Version 1.0.0.1, Accuray Precision Treatment Planning System, The Accu
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.
Software, Version 1.0, Precision Treatment Planning SystemThe Accuray Precision
Software, Version 1.0, Precision Treatment Planning SystemThe 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.
The Onrad™ Treatment System is a radiation therapy system that integrates planni
The Onrad™ Treatment System is a radiation therapy system that integrates planning, dosecalculation, megavoltage CT imaging for IGRT functionality, and fixed beam (non-rotational)radiation therapy treatment capabilities into a single comprehensive system.The Onrad™ Treatment System is a prescription device. It delivers radiation in accordancewith a physician approved plan. The device does not diagnose disease, recommend treatmentregimens, or quantify treatment effectiveness. The megavoltage CT imaging functionality isnot intended for diagnostic use.
Software, TomoApps, Version 2.1.1, Build # 5.1.1(Operating Software for TomoTher
Software, TomoApps, Version 2.1.1, Build # 5.1.1(Operating Software for TomoTherapy systems, including TomoH®, TomoHD®, TomoHDA™ and Onrad™)
Radiance V4 is a software system intended for treatment planning and analysis of
Radiance V4 is a software system intended for treatment planning and analysis of radiation therapy administered with devices suitable for intraoperative radiotherapy.The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user.The system functionality can be configured based on user needs.The intended users of Radiance V4 shall be clinically qualified radiation therapy staff trained in using the system.
Radiance V3 is a software system intended for treatment planning and analysis of
Radiance V3 is a software system intended for treatment planning and analysis of radiation therapy administered with devices suitable for intraoperative radiotherapy.The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user.The system functionality can be configured based on user needs.The intended users of Radiance V3 shall be clinically qualified radiation therapy staff trained in using the system.