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Advanced Viewer is a web based software for medical professionals that provides doctors with tools for secure online image (DICOM) review including measurement functions and the display of voxel objects. It is not intended for detailed treatment planning, treatment of patients or the review of mammographic images. It is also not intended to be used on mobile systems.

Advanced Viewer is integrated in the online collaboration platform Quentry to share, discuss and transfer medical image data. The viewer provides capabilities to visualize medical images (DICOM) that have been uploaded to the platform before. Quentry is a software platform consisting of a set of server-based components providing functions for transfer and storage of medical data, as well as user access via a web-based portal for data management, sharing, and download. The platform is integrated with desktop and server-based applications for upload and download of medical data from workstations and network-based image archive servers. The platform also provides interfaces for integration of third-party systems and applications. Quentry platform is an FDA class I product.

DASH hip is intended to be an intraoperative image-guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. The system is indicated for any medical condition in which the use of stereotactic surgery may be considered to be safe and effective, and where a reference to a rigid anatomical structure, such as a long bone, can be identified relative to the anatomy. The system aids the surgeon in controlling leg length and offset discrepancies. Example orthopedic surgical procedures include but are not limited to: Total Hip Replacement (THR) Revision surgery of THR Minimally Invasive THR Surgery

DASH hip is intended to enable operational navigation in minimally invasive orthopedic surgery. It links a surgical instrument, tracked by passive markers to virtual computer image space on an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks.on the bone surface. DASH hip uses the registered landmarks to determine postoperative changes in leg length and offset, DASH hip software intraoperatively registers the patient data needed for navigating the surgery. No preoperative CT-scanning is necessary.

iPlan RT is a radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions.

iPlan RT is a software program to generate treatment plans and to simulate the dose delivery for external beam radiotherapy. The system is the evolutionary successor of the predicate devices iPlan RT Image (K080886) and iPlan RT Dose (K080888). It is specialized for stereotactic procedures for cranial as well as extracranial lesions. It includes functions for all relevant steps from outer contour detection to quality assurance. It combines most of its predecessor's functionality iPlan RT Image and iPlan RT Dose together with additional improvements. Therefore, the new version shall be called "iPlan RT". The device incorporates conformal beams, conformal IMRT beams, circular arcs, and both static and dynamic arc treatments. Moreover, a combination of optimized dynamic arc treatments together with IMRT beams was added to the treatment modalities. The system calculates dose using a convolution algorithm as the previous version. Alternatively, a Monte Carlo method based calculation algorithm can be used as in iPlan RT Dose (K080888). The documentation & export function facilitates printouts of all parameters and results for the creation of DICOM RT (RT Plan and RT Image) files. Adapting existing treatment plans during fractionated radiotherapy treatments is facilitated using an elastic deformation algorithm. Existing structures are morphed from an existing treatment plan onto a new follow-up scan. If necessary, these structures can be adapted by the physician and can be used to update the current treatment plan accordingly.

Disposable reflective marker spheres are attached to reference arrays and instruments, thus enabling infrared tracking systems to detect the position of the patient and instruments in the surgical field.

A disposable reflective marker sphere consists of two bonded half spheres and a screw part that is cut in the lower sphere. An adhesive combines the upper and lower half spheres. The raw sphere is covered with a defined retro-reflective foil.

The Digital Lightbox is a system intended for the retrieval and display of medical images from picture archiving and communication systems (PACS), file servers, or removable storage media. It includes functions for image manipulation, 3D reconstruction, basic measurements, and multi-modality image fusion. It is not intended for primary image diagnosis or the review of mammographic images.

Digital Lightbox is a medical image viewing device consisting of two high-resolution monitors controlled through touch panels with an integrated PC. It features an Ethernet connection for retrieving medical images through a computer network. Further, the device can read images from CD, DVD or USB drives through external interfaces. The device software is compatible with the DICOM standard and allows basic image manipulation, 3D reconstruction, basic measurements and multi-modality image fusion. The device software integrates a web browser and remote access software.

BrainLAB VectorVision trauma is intended to be a pre- and intraoperative image quided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's pre- or intraoperative image data being processed by a VectorVision workstation. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, a bone structure like tubular bones, pelvic, calcaneus and talus, or vertebra, can be identified relative to a CT, fluoroscopic, X-ray or MR based model of the anatomy. Example procedures include but are not limited to: Spinal procedures and spinal implant procedures such as pedicle screw placement. Pelvis and acetabular fracture treatment such as screw placement or illo-sacral screw fixation. Fracture treatment procedures, such as intramedullary nailing or screwing or external fixation procedures in the tubular bones.

BrainLAB VectorVision trauma is intended to enable operational navigation in spinal, orthopedic and traumatologic surgery. It links a surgical instrument, tracked by flexible passive markers to virtual computer image space on a patient's intraoperative image data being processed by a VectorVision workstation. VectorVision trauma allows navigation of intraoperatively acquired images considering patient's movement in correlation to calibrated surgical instruments. This allows implant positioning, screw placement and bone reduction in different views and reduces the need for treatments under permanent fluoroscopic radiation.

BrainLAB's VectorVision® hip SR is intended as an intraoperative image-guided localization system. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a VectorVision® navigation station. The image data is provided either in the form of preoperatively-acquired patient images or in the form of an individual 3D model of the patient's bone, which is generated by acquiring multiple landmarks on the bone surface. The system is indicated for any medical condition in which the use of stereotactic surgery may be considered to be appropriate and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT, X-ray, or MR-based model of the anatomy. The system aids the surgeon in accurately navigating a hip endoprothesis to the preoperatively or intraoperatively planned position. Example orthopedic surgical procedures include but are not limited to: · Partial/hemi-hip resurfacing

BrainLAB's VectorVision® hip SR is intended to enable operational planning and navigation in orthopedic hemi resurfacing surgery. It links a surgical instrument, tracked by flexible passive markers to virtual computer image space on an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. VectorVision® hip SR uses the registered landmarks to navigate the initial pin insertion into the femur with a pre-calibrated drillguide to the planned position. VectorVision® hip SR allows 3-dimensional reconstruction of the relevant anatomical axes and planes of the femur and alignment of the implants. The VectorVision® hip SR software has been designed to read in data of implants and tools if provided by the implant manufacturer and offers to individually choose the prosthesis during each surgery. If no implant data is available it is possible to provide information in order to achieve a generally targeted alignment relative to the bone orientation as defined by the operating surgeon. The VectorVision® hip SR software registers the patient data needed for planning and navigating the surgery intraoperatively without CT-based imaging. The system can be used to generally align tool orientations according to the anatomy described and defined by the landmarks acquired by the surgeon.

Ci TKR/UKR is intended to be an intraoperative image guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT, X-ray, MR based model of the anatomy. The system aids the surgeon to accurately navigate a knee prosthesis to the intraoperatively planned position. Ligament balancing and measurements of bone alignment are provided by Ci TKR/UKR. Example orthopedic surgical procedures include but are not limited to: Knee Procedures: Total Knee Replacement Unicondylar Knee Replacement Ligament Balancing Range of Motion Analysis Cruciate Ligament Surgery Patella Tracking

Ci TKR/UKR is intended to enable operational planning and navigation in orthopedic surgery. It links a surgical instrument, tracked by flexible passive markers to virtual computer image space on an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. Ci TKR/UKR uses the registered landmarks to navigate the femoral and tibial cutting guides and the implant to the planned optimally position. Ci TKR/UKR allows 3-dimensional reconstruction of the mechanical axis and alignment of the implants. Ci TKR/UKR software registers the patient data needed for planning and navigating the surgery intraoperatively. No preoperative CT-scanning is necessary. Ci TKR/UKR software has been designed to read in implant data from DePuy and offers to individually choose the prosthesis during each surgery. The CAS Knee Instrumenation (K-043223) developed and manufactured by DePuy is integrated in the Ci TKR/UKR software. Together, instruments and hardware/software enable operational planning and navigation during minimally invasive orthopaedic knee replacement surgery.

iPlan's indications for use is to prepare and present patient and image data based on CT, MR, Xray(Fluoro), including - . image preparation - . image fusion - image segmentation . where the result is used for the creation of treatment plans for Stereotactic Surgery: - Surgery Planning - BrainMAP - Functional Planning In addition iPlan's indications for use is to prepare and present patient and image data based on CT, MR, X-ray(Fluoro) including - . image preparation - . image fusion - image segmentation . where the result is preplanned data to be used by other BrainLAB medical devices such as VectorVision (for performing the planned treatment) where these medical devices are used for: - Image Guided Surgery - FiberTracking - BOLD MRI iPlan BOLD MRI indication for use is to prepare image data based on BOLD (blood oxygen level dependent) MRI scan studies and display the result as parametric images. When interpreted by a trained physician or surgeon this information may be used with other anatomical information for planning and image guided surgery.

The BrainLAB iPlan BOLD MRI module is software used for processing BOLD (blood oxygen level dependent) MRI sequences and display of calculation results. The slight MRI susceptibility changes between the images are visualized as parametric images.

iPlan!'s indications for use is to prepare and present patient and image data based on CT, MR, X-ray (Fluoro), including - image preparation - - image fusion - image segmentation - where the result is used for the creation of treatment plans for Stereotactic Surgery: - Surgery Planning - BrainMAP - Functional Planning In addition iPlan!'s indications for use is to prepare and present patient and image data based on CT, MR, X-ray (Fluoro) including - image preparation - - image fusion - image segmentation - where the result is preplanned data to be used by other BrainLAB medical devices such as VectorVision (for performing the planned treatment) where these medical devices are used for: Image Guided Surgery BrainLAB's Image Guided Surgery system is intended to be an intraoperative image guided localization system to enable minimally invasive surgery where the image guided surgery system is indicated for any medical condition in which the use of stereotactic surgery may be considered to be appropriate and where a reference to a rigid anatomical structure, such as the skull, a long bone, or verfebra, can be identified relative to a CT, X-ray or MR based model of the anatomy. Example procedures include but are not limited to: - Cranial procedures - -Spine procedures - -ENT procedures Additional Indications For Use: iPlan! FiberTracking's indication for use is to prepare and present patient and image data based on MRI scanned with diffusion-weighted sequences. These diffusion images are used for the calculation and display of fiber bundles in a selected region of interest. The created treatment plans of iPlan! FiberTracking can be used with other iPlan! treatment plans and other BrainLAB medical devices such as VectorVision, where this medical device is used for image guided surgery.

iPlan! FiberTracking is developed to enhance functionality of iPlan! Cranial software with the import and planning of diffusion tensor images (DTI). Additional to the basic functions of iPlan! (viewing, drawing, image fusion and planning) this application provides functions for the import and display MRI anisotropic data, image processing of the DTI data and the display of the calculated fiber tracts.