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The X-ray Imaging System controls the x-ray generation, image processing and patient registration of the McLaren Proton Treatment System. The software product described by this document is considered a sub-system of the MPTS.
The software product integrates with the following components of the MPTS system:
• X-ray generator & tube assembly
• Amorphous silicon flat-panel detector
• Electro-mechanical controls of the imaging c-ring to enable system positioning and rotation around the patient
The software will permit a radiation technician to set the desired energy levels and field of view. Once set the software can acquire orthogonal or CBCT x-ray images of the region of interest. When images are acquired the software will process them to create viewable images for patient location registration. The patient location registration workflow will locate the treatment isocenter, defined in the patient anatomy, relative to the desired position in the treatment room through which the beam passes. The location of the treatment isocenter is established during treatment planning with 3D planning images (CT simulation images). The patient’s position will be adjusted, if needed, based on a comparison of the current patient location, the defined treatment plan, and previously acquired Digitally Reconstructed Radiographs or CTs.
There are two defined methods of registration,
1. Digitally Reconstructed Radiographs (DRRs) from 3D planning images are compared to the 2D images taken during patient setup in order to compare the patient anatomy with the expected location and orientation given by the DRRs. The registration tool is implemented to display both the downloaded DRRs, provided by the treatment planning system, and the display of the new 2D images, acquired by x-ray imaging system.
2. 3D planned volume images are compared to the CBCT volumetric (CTs) images taken during patient setup in order to compare the patient anatomy with the expected location and orientation. The regis
EhmetDx LLC
v.1.x
In Commercial Distribution
- 00866854000401 ()
n/a
- CT system application software
IMAGEXL XRAY SOFTWARE VERSION 4 BASE
PROFESSIONAL ECONOMICS BUREAU OF AMERICA INC
4
In Commercial Distribution
- 00861787000306 ()
- General-purpose dental x-ray system application software
The ExamVue PACS is a software solution for the storage, sharing, display and viewing for diagnosis of medical images. It consists of two software components, a central database and server software that holds, receives and distributes images, and a viewer program that can be installed on multiple computers for viewing, modifying, making measurements on, and displaying the images in the database.
JPI HEALTHCARE. CO., LTD.
ExamVue PACS
In Commercial Distribution
- 08809413810174 ()
- Basic diagnostic x-ray system application software
The ExamVue DR software is designed for use by radiologists and radiology technicians for the acquisition of digital x-ray images. It interfaces with 3rd party digital x-ray detectors or CR scanners and manufacturer supplied software for the acquisition and storage of digital x-ray images. The ExamVue DR software then provides a user interface for the viewing, annotating, and other workstation functions. ExamVue DR includes the ability to receive patient information and send x-ray images to remote destinations using the DICOM 3.0 protocol.
JPI HEALTHCARE. CO., LTD.
ExamVue DR
In Commercial Distribution
- 08809413810143 ()
- Basic diagnostic x-ray system application software
ExamVue Duo is a software program designed to provide image acquisition, processing and operational management functions for digital radiography and use by radiologists and radiology technicians. ExamVue Duo saves the digital X-ray images acquired from the detector and process it to make the better image quality. The software also manages patient information, capture, and store diagnostic images in an internal database. It also supports DICOM 3.0 protocol which allows compatibility with the network programs such as the PACS system.
JPI HEALTHCARE. CO., LTD.
ExamVue Duo
In Commercial Distribution
- 08809413810679 ()
- Basic diagnostic x-ray system application software
The ExamVue DR software is designed for use by radiologists and radiology technicians for the acquisition of digital x-ray images. It interfaces with 3rd party digital x-ray detectors or CR scanners and manufacturer supplied software for the acquisition and storage of digital x-ray images. The ExamVue DR software then provides a user interface for the viewing, annotating, and other workstation functions. ExamVue DR includes the ability to receive patient information and send x-ray images to remote destinations using the DICOM 3.0 protocol.
JPI HEALTHCARE. CO., LTD.
ExamVue DR
In Commercial Distribution
- 08809413810488 ()
- Basic diagnostic x-ray system application software
The ExamVue PACS is a software solution for the storage, sharing, display and viewing for diagnosis of medical images. It consists of two software components, a central database and server software that holds, receives and distributes images, and a viewer program that can be installed on multiple computers for viewing, modifying, making measurements on, and displaying the images in the database.
JPI HEALTHCARE. CO., LTD.
ExamVue PACS
In Commercial Distribution
- 08809413810471 ()
- Basic diagnostic x-ray system application software
Vectus Small Sapphire Optic Refurbished
Cynosure, LLC
3520A-0003R
In Commercial Distribution
- 00841494100636 ()
- Dermatological Raman spectroscopy system
Vectus Handpiece Refurbished
Cynosure, LLC
3520A-0001R
In Commercial Distribution
- 00841494100612 ()
- Dermatological Raman spectroscopy system
Vectus Large Sapphire Optic Refurbished
Cynosure, LLC
3520C-0002R
In Commercial Distribution
- 00841494100162 ()
- Dermatological Raman spectroscopy system
Vectus Small Sapphire Optic
Cynosure, LLC
3520A-0003
In Commercial Distribution
- 00841494100148 ()
- Dermatological Raman spectroscopy system
Vectus Laser Assembly
Cynosure, LLC
105-3500-000
In Commercial Distribution
- 00841494100124 ()
- Dermatological Raman spectroscopy system
Vectus Large Sapphire Optic
Cynosure, LLC
3520C-0002
In Commercial Distribution
- 00841494100155 ()
- Dermatological Raman spectroscopy system
Vectus Diode Handpiece
Cynosure, LLC
3520A-0001
In Commercial Distribution
- 00841494100131 ()
- Dermatological Raman spectroscopy system
No Description
Advanced Bionics, LLC
CI-6101
Not in Commercial Distribution
- 07630016817137 ()
- Hearing implant implantable-component tester, postoperative
No Description
Advanced Bionics, LLC
AB-6500
Not in Commercial Distribution
- 07630016809705 ()
- Hearing implant implantable-component tester, postoperative
No Description
Advanced Bionics, LLC
CI-6101
Not in Commercial Distribution
- 07630016841552 ()
- Hearing implant implantable-component tester, postoperative
The Lung Image Analysis (LIA) software is designed to aid in the interpretation of Computed Tomography (CT) scans of the thorax that may contain pulmonary abnormalities. Lung Image Analysis has both a graphical user interface and command-line software which can be run as a Windows application or from a command-line interpreter. The LIA software is to be used by trained professionals who are responsible for the correct and accurate use of medical images. In a typical clinical environment, the results provided by the software are used together with other clinical information by a medical professional.
The software may be installed on an off-the-shelf PC computer system and is intended to be used with uncompressed digital images that are saved in DICOM format.
PULMONX CORPORATION
LIA-01-001
In Commercial Distribution
- 00811907031819 ()
- CT system application software
Dental imaging software
CYBER MEDICAL IMAGING, INC.
Imaging Software
In Commercial Distribution
- D787XDRSW300 ()
XDRSW30
- General-purpose dental x-ray system application software
Dental imaging software
CYBER MEDICAL IMAGING, INC.
Imaging Software
In Commercial Distribution
- D787XDRSW1 ()
XDRSW
- General-purpose dental x-ray system application software
Monarch Software Laptop v2.2.1
AURIS HEALTH, INC.
Version 2.2.1
In Commercial Distribution
- B634SW0121940202000 ()
- CT system application software
Monarch Software Laptop v2.1.6
AURIS HEALTH, INC.
Version 2.1.6
In Commercial Distribution
- B634SW0121900201060 ()
- CT system application software
Monarch™ Software Laptop v2.1.5
AURIS HEALTH, INC.
Version 2.1.5
In Commercial Distribution
- B634SW0032760201050 ()
- CT system application software
Monarch™ Software Laptop v2.1.4
AURIS HEALTH, INC.
Version 2.1.4
In Commercial Distribution
- B634SW0032760201040 ()
- CT system application software
Monarch™ Software Laptop v2.1.3
AURIS HEALTH, INC.
Version 2.1.3
In Commercial Distribution
- B634SW0032760201030 ()
- CT system application software
Monarch™ Software Laptop v2.1.2
AURIS HEALTH, INC.
Version 2.1.2
In Commercial Distribution
- B634SW0032760201020 ()
- CT system application software
No Description
ELUCID BIOIMAGING INC.
A.2
In Commercial Distribution
- B745VASCUCAPA2 ()
- CT system application software
No Description
ELUCID BIOIMAGING INC.
A.3
In Commercial Distribution
- B745ELUCIDVIVOA3 ()
- CT system application software
No Description
ELUCID BIOIMAGING INC.
A.1.2
In Commercial Distribution
- B745A40 ()
- CT system application software
No Description
QUALITY ELECTRODYNAMICS LLC
2001001
In Commercial Distribution
- 00814848020232 ()
MAC000112
- Radiation therapy simulation system
No Description
QUALITY ELECTRODYNAMICS LLC
2001000
In Commercial Distribution
- 00814848020218 ()
MAC000111
- Radiation therapy simulation system
This Radiographic System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic
radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography
SEDECAL
MULTIRAD NET
In Commercial Distribution
- 08436046001923 ()
- Stationary basic diagnostic x-ray system, analogue
The SEDECAL X BRS (BRX) Diagnostic Radiographic System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography
SEDECAL
SEDECAL X BRS (BRX)
In Commercial Distribution
- 08436046001909 ()
- Stationary basic diagnostic x-ray system, analogue
This Portable Diagnostic Radiographic System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography)
SEDECAL
SPSL-HF-8.0-APR
In Commercial Distribution
- 08436046001855 ()
- Portable basic diagnostic x-ray system, analogue
The SEDECAL X URS Radiographic System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
SEDECAL
SEDECAL X URS
- Stationary basic diagnostic x-ray system, analogue
This Portable Diagnostic Radiographic System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography)
SEDECAL
SPSL-HF-4.0-APR
In Commercial Distribution
- 08436046001848 ()
- Portable basic diagnostic x-ray system, analogue
This Portable Diagnostic Radiographic System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography)
SEDECAL
SPSL-HF-8.0
In Commercial Distribution
- 08436046001831 ()
- Portable basic diagnostic x-ray system, analogue
This Portable Diagnostic Radiographic System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography)
SEDECAL
SPSL-HF-4.0
In Commercial Distribution
- 08436046001824 ()
- Portable basic diagnostic x-ray system, analogue
This Portable Diagnostic Radiographic System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography)
SEDECAL
SPL-HF-8.0
In Commercial Distribution
- 08436046001794 ()
- Portable basic diagnostic x-ray system, analogue
This Portable Diagnostic Radiographic System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography)
SEDECAL
SPL-HF-4.0
In Commercial Distribution
- 08436046001787 ()
- Portable basic diagnostic x-ray system, analogue