Search Results

The dS Breast Coil 7ch 1.5T is intended to be used in conjunction with a Philips Prodiva 1.5T CX and a MR 5300 1.5T Magnetic Resonance Scanner to produce diagnostic images of the breast, chest wall, and axillary tissues that can be interpreted by a trained physician.

The dS Breast Coil 7ch 1.5T is a 7-element phased array receive only coil to be used on a 70cm bore Philips 1.5T MR Systems. The coil is designed to work in unison with the Body Coil of the MRI system, which will transmit the radio frequency (RF) signals, so that the coil may receive the resultant RF signal from the excited nuclei. The subject coil is designed to be used in conjunction with Philips Prodiva 1.5T CS and 1.5T CX MR System (K173507) and with Philips MR 5300 System (K212673) with dStream interfaces. The subject coil is designed for optimum coverage and high-resolution visualization of detailed cartilage structures of the breast anatomy. The coil is used independently and cannot be combined with any other coils. The coil is only available in 1.5T version. The open coil housing design of the dS Breast Coil 7ch 1.5T allows for lateral-medial and cranial-caudal access to the breast for both diagnostic breast imaging and interventional exams.

The 8ch Wrist Coil is intended to be used in conjunction with a SIGNA Prime Magnetic Resonance scanner to produce diagnostic images of the wrist anatomy that can be interpreted by a trained physician.

The 8ch Wrist Coil magnetic resonance (MR) coil is a receive only phased array coil with 8 channels for wrist imaging. This Wrist Coil is designed for use with the SIGNA Prime (K211980). The 8ch Wrist Coil is designed to be used vertically at the patient's side or horizontally overhead. The wrist array comes with two rigid base plates (for flat or curved tabletops) for fixation to reduce patient motion. The coil receives magnetic resonance signals generated in hydrogen nuclei (protons) in the wrist while blocking the high-frequency B1 field applied by the MRI scanner at specified timing. The 8ch Wrist Coil is tuned to receive RF frequency corresponding to the proton precession in a 1.5 tesla magnetic field, which is governed by the Larmor equation. Images are typically generated as axial, sagittal, coronal oblique slices and include coverage of the wrist anatomy.

The 1.5T T/R Quad Extremity Coil is intended to be used in conjunction with a SIGNA Prime Magnetic Resonance Scanner to produce diagnostic images of the lower extremities that can be interpreted by a trained physician. The 1.5T 8CH T/R Knee Coil is intended to be used in conjunction with a SIGNA Prime Magnetic Resonance Scanner to produce diagnostic images of the knee that can be interpreted by a trained physician.

The 1.5T T/R Quad Extremity Coil is quadrature Transmit and Receive coils. At 1.5T the coil can be used in 3 different operational modes: QuadKnee, QuadFoot and QuadAnkle. The coil is designed to image the Knee, Foot and Ankle, but can also be used for other parts of the lower extremities. The base of the coil is attached to a base plate and can be moved to scan either the Left or Right extremity. The coil is moved into position (Left to Right) and locked into place, the patient is then positioned in the base, the top section of the coil is placed over the patient and the latched closed. The fixed position of the coil and helps prevent the patient form moving, reducing artifact. This coil is used independently and can't be combined with any other coils. The 1.5T T/R Quad Extremity Coil is compatible with SIGNA Prime MRI Systems with P-Port Connector. It consists of a birdcage quadrature coil. During transmit phase, the coil is resonated by the RF power source of MR system, to excite hydrogen nuclei (protons) in the anatomy. The quadrature coil detects the magnetic resonance signals generated by hydrogen nuclei (protons) in the knee during the receive phase. The coil is tuned to transmit and receive RF frequency corresponding to the proton precession in a 1.5 tesla magnetic field, which is governed by the Larmor equation. The 1.5T 8CH T/R Knee Coil is an 8 element phase array coil with a T/R quadrature birdcage shell, designed to image the knee. The base of the coil is attached to a base plate and can be moved to scan either the Left or Right Knee. The patient is positioned in the base, the top section of the coil is placed over the patient and the latched closed, which locks the position of the coil and helps prevent the patient form moving, reducing artifact. The transmit shell consist of a twist birdcage quadrature coil, resonated by the RF power source of MR system, to excite hydrogen nuclei (protons) in the anatomy. The coil receivers consist of 8 phased array elements that detect the magnetic resonance signals generated by hydrogen nuclei (protons) in the knee while blocking the high-frequency B1 field applied by the coil transmit shell at specified timings. The coil is tuned to transmit and receive RF frequency corresponding to the proton precession in a 1.5 tesla magnetic field, which is governed by the Larmor equation. This coil is used independently and cannot be combined with any other coils. The 1.5T T/R Quad Extremity Coil and 1.5T 8CH T/R Knee Coil are compatible with SIGNA Prime MRI systems with a P-Port connector.

The dS Sentinelle Breast 16ch 3T Coil are intended to be used in conjunction with Philips 3.0T Magnetic Resonance Scanners to produce diagnostic images of the breast anatomy that can be interpreted by a trained physician. When used with a disposable biopsy grid, the device permits access to breast anatomy for biopsy and localization procedures.

The dS Sentinelle Breast 16 Ch 3.0T MR Coils is a receive only coil to be used on a 70cm bore Philips Ingenia 3.0T MR System. The coil arrays are designed to correspond with the scanner strength. The dS Sentinelle Breast 16Ch 3T coil is a phased array design consisting of patient support with three different coil configurations (2, 10 or 16 channels): 1. 16Ch for diagnostic imaging: performed in 16Ch configuration that consists of two dS Sentinelle Lateral 4Ch coils and the dS Sentinelle Medial 8Ch coil. 2. 10Ch for bilateral interventional procedures requiring lateral access: performed in 10Ch configuration that consists of the dS Sentinelle Medical 8Ch coil and two dS Sentinelle Lateral 1Ch coils (right and left). 3. 2Ch for unilateral interventional procedures allowing both lateral and medial access: performed in 2Ch configuration that consists of two dS Sentinelle Lateral 1Ch coils (right and left). The coils receive magnetic resonance signals generated in hydrogen nuclei (protons) in the Breast while blocking the high-frequency magnetic field applied by the MRI scanner at specified timings. The coil arrays include 4Ch right and left lateral coils, a medial coil and 1Ch right and left lateral biopsy coils. Images are typically generated as axial, sagittal, coronal and oblique slices and include full coverage of the breast anatomy. The dS Sentinelle Breast 16Ch 3T Coil is tuned to receive RF frequency corresponding to the proton precession in a 3.0 tesla magnetic field (respectively), which is governed by the Larmor equation. The Variable Coil Geometry design of the dS Sentinelle Breast 16Ch 3T Coil allows each imaging element to be independently positioned and configured for each patient. Patients can then be positioned quickly and effectively as the imaging elements can be positioned as close to the breast as possible optimizing the signal-to-noise ratio for each individual patient. For clinical imaging, coil housings are placed next to the tissue to help minimize motion artifacts due to patient motion during scanning. The subject dS Sentinelle Breast Coil system also includes a tabletop compression system which facilitates immobilization of the breast for imaging and interventional procedures and serves to hold the individual imaging coils in proximity to the breast(s). The intent of this is to reduce motion artifacts and ensure the imaging elements are positioned as close to the breast(s) as possible to optimize signal-to-noise ratio and image quality.

The dS Sentinelle Breast 16ch 1.5T Coil is intended to be used in conjunction with Philips 1.5T Magnetic Resonance Scanners to produce diagnostic images of the breast anatomy that can be interpreted by a trained physician. When used with a disposable biopsy grid, the device permits access to breast anatomy for biopsy and localization procedures.

The dS Sentinelle Breast 16ch 1.5T Coil is a receive only coil to be used on a 70cm bore Philips Ingenia 1.5T MR System. The coil arrays are designed in a magnetic strength (1.5T) to correspond with the scanner strength. The dS Sentinelle Breast 16ch 1.5T Coil is a phased array design consisting of patient support with three different coil configurations (2, 10 or 16 channels): 1. 16Ch for diagnostic imaging: performed in 16ch configuration that consists of two dS Sentinelle Lateral 4Ch coils and the dS Sentinelle Medial 8Ch coil. 2. 10Ch for bilateral interventional procedures requiring lateral access: performed in 10Ch configuration that consists of the dS Sentinelle Medical 8ch coil and two dS Sentinelle Lateral 1ch coils (right and left). 3. 2Ch for unilateral interventional procedures allowing both lateral and medial access: performed in 2Ch configuration that consists of two dS Sentinelle Lateral 1Ch coils (right and left). The coils receive magnetic resonance signals generated in hydrogen nuclei (protons) in the Breast while blocking the high-frequency magnetic field applied by the MRI scanner at specified timings. The coil arrays include 4Ch right and left lateral coils, a medial coil and 1Ch right and left lateral biopsy coils. Images are typically generated as axial, sagittal, coronal and oblique slices and include full coverage of the breast anatomy. The dS Sentinelle Breast 16ch 1.5T Coil is tuned to receive RF frequency corresponding to the proton precession in a 1.5 tesla magnetic field, which is governed by the Larmor equation. The Variable Coil Geometry design of the dS Sentinelle Breast 16ch 1.5T Coil allows each imaging element to be independently positioned and configured for each patient. Patients can then be positioned quickly and effectively as the imaging elements can be positioned as close to the breast as possible optimizing the signal-to-noise ratio for each individual patient. For clinical imaging, coil housings are placed next to the tissue to help minimize motion artifacts due to patient motion during scanning. The subject dS Sentinelle Breast 16ch 1.5T Coil system also includes a tabletop compression system which facilitates immobilization of the breast for imaging and interventional procedures and serves to hold the individual imaging coils in proximity to the breast(s). The intent of this is to reduce motion artifacts and ensure the imaging elements are positioned as close to the breast(s) as possible to optimize signal-to-noise ratio and image quality.

The dS FootAnkle 16ch 1.5T and 3.0T MR Coils are intended to be used in conjunction with Philips 1.5T/3.0T Magnetic Resonance Scanners to produce diagnostic images of the foot and ankle anatomy that can be interpreted by a trained physician. The dS HiRes Hand/Wrist 16ch 1.5T and 3.0T MR Coils are intended to be used in conjunction with Philips 1.5T/3.0T Magnetic Resonance Scanners to produce diagnostic images of the hand and wrist anatomy that can be interpreted by a trained physician. The dS Small Extremity 16ch 1.5T and 3.0T MR Coils are intended to be used in conjunction with Philips 1.5T/3.0T Magnetic Resonance Scanners to produce diagnostic images of the small extremities anatomy on adult and pediatric patients that can be interpreted by a trained physician.

The Philips Orthopedic MR Coils are designed for use with Magnetic Resonance Imaging (MRI) systems. The coils are designed to work in unison with the Body Coil of the MRI system, which will transmit the radio frequency (RF) signals, so that the coil may receive the resultant RF signal from the excited nuclei. The subject devices have 16-elements and are for use with Philips Ingenia 1.5T and 3.0T MR Systems with dStream interface (K193215). The devices are designed for optimum coverage and high-resolution visualization of detailed cartilage structures of the body anatomy (foot/ankle, hand/wrist, small extremity). The coil is used independently and cannot be combined with any other coils. The coils are available in both 1.5T and 3.0T magnetic strengths.

The dS Head 32ch 3.0T MR Coil is intended to be used in conjunction with a Philips 3.0T Magnetic Resonance Scanner to produce diagnostic images of the head on adult and pediatric patients that can be interpreted by a trained physician.

The subject dS Head 32ch 3.0T Coil is a receive-only, phased-array radiofrequency (RF) coil designed for high-resolution head examinations on adult and pediatric patients. The coil is intended for use with Philips magnetic resonance (MR) scanners with a 3.0 tesla magnetic field strength.

The MR Patient Care Portal 5000 is intended for use by healthcare professionals. The device is indicated for use to monitor vital signs of patients undergoing MRI procedures including ECG, pulse oximetry (SpO2), non-invasive blood pressure (NIBP), and optionally, invasive pressure (IP), carbon dioxide (CO2) and respiration rate, anesthetic agents, nitrous oxide (N2O), oxygen (O2), and/or temperature based on the configurations of the host patient monitor with which the MR Patient Care Portal 5000 is wirelessly communicating. The target patient population includes adult, pediatric, and neonatal patients that require monitoring during MRI procedures.

The Philips MR Patient Care Portal 5000 is an information portal that serves as a remote monitor and remote control with electronic medical records capabilities outside the MR Scanner room (i.e. Control Room, Induction Room, or Recovery Room). The Philips MR Patient Care Portal 5000 displays the vital signs of a single patient monitoring system with which the device is communicating with from the MR control room. The Philips MR Patient Care Portal 5000 is intended to replace the substantially equivalent device, the Expression Information Portal (Model IP5), cleared under 510(k) K121424 as a remote display and remote control for host patient monitoring systems, the Expression Model MR400 MRI Patient Monitoring System and Expression MR200 MRI Patient Monitoring System. The Philips MR Patient Care Portal 5000 is not designed to be used in the MR Scanner room, does not perform any data collection or processing of data as stand-alone patient monitoring system, and it is not a central station. The Philips MR Patient Care Portal 5000 system consists of the following primary components: - Desktop unit; - Radio Kit, USB; - . Radio Cradle: - Display, 18.5 inch;

DynaCAD is a MR image analysis software medical device used during clinical diagnosis, reporting, and interventional pre-planning and is intended to assist the physician through a series of sequential tasks. DynaCAD consists of: • MR Analysis Server post-processing software application facilitates the analysis of dynamic MR datasets to provide study review, lesion characterization, and additional mathematical and/or statistical analysis. · Viewer application facilitates the analysis and presentation of datasets generated by the MR Analysis Server. · Interventional Planning image-guidance application for diagnostic and interventional procedure planning for biopsy and/ or soft tissue ablation. DynaCAD is indicated for medical conditions that require interventional and/or diagnostic procedures of the prostate gland or breast tissue.

DynaCAD is a MR image analysis software only medical device used during clinical diagnosis, reporting, and interventional pre-planning and is intended to assist the physician through a series of sequential tasks. DynaCAD consists of: - . MR Analysis Server post-processing software application, which facilitates the analysis of dynamic and non-dynamic MR datasets to provide study review, lesion characterization, and additional mathematical and/or statistical analysis. It includes the following software modules: DynaCAD Breast, DynaCAD Prostate, DynaLOC Breast, DynaLOC Prostate, and PK MRI Analysis. - . Viewer application, which facilitates the analysis and presentation of datasets generated by the MR Analysis Server. It includes the following functions: Region of Interest (ROI) curve, Pixel of Interest (POI) curve, Report Card, Volume Calculation, Statistical Analysis, 3-D visualization of image series, and DICOM reporting, among other capabilities. - Interventional Planning image-guidance application, i.e. Ablation Planning, which facilitates diagnostic and interventional procedure planning for biopsy and/or soft tissue ablation. It helps the user to prepare for ablation procedures by presenting the target regions along with critical structures identified in MR, and previously acquired biopsy data. It provides information about the ablation devices and applicators for automatic ablation plan computation, which the user can adjust as necessary. DynaCAD is used in both the radiology, i.e. DynaCAD Radiology, and urology domain, i.e. DynaCAD Urology.

UroNav is a stereotaxic accessory for image-guided interventional and diagnostic procedures of the prostate gland. It provides 2D and 3D visualization of Ultrasound (U/S) images and register these images with those from other imaging modalities such as Magnetic Resonance (MR). It also provides the ability to display a simulated image of a tracked insertion tool such as a biopsy needle, guidewire, grid plate or probe on a computer monitor screen that shows images of the target organ and the current and the projected future path of the interventional instrument taking into account patient movement. Other software features include patient data management, multiplanar reconstruction. segmentation, image measurements and 2D/3D image registration. UroNav is intended for treatment planning and guidance for clinical, interventional and/or diagnostic procedures. The device is intended to be used in interventional and diagnostic procedures in a clinical setting. Example procedures include, but are not limited to image fusion for diagnostic clinical examinations and procedures, soft tissue ablations and placement of fiducial markers.

UroNav System is a medical image processing system that provides image-guided intervention and diagnostic information, which guides interventional instrumentation to targets that have been defined by the physician. The target can be indicated either pre-procedurally or intraprocedurally using images or relative to an indicated position on the patient. As a diagnostic system, it combines pre-procedural and intraprocedural imaging to assist in locating areas of interest detected on one set of images on the other. The system provides fusion between Ultrasound (US) and different imaging modalities such as Magnetic Resonance Imaging (MR). When used as a navigation aid, it also transforms two and three-dimensional patient images (scan sets) into dynamic representations on which a medical instrument can be navigated. The system performs spatial mapping from one image space to another image space or from image space to physical space ("registration") allowing the physician to correlate scan sets with each other and to the patient. The system facilitates minimally invasive interventional procedures. Images used by UroNav can include archived image data from a CD, PACS, etc., and live images from an ultrasound system. The UroNav system consists of an Electromagnetic Measurement System (EMMS) (including a Field Generator, System Control Unit and System Interface Unit(s)), a System Unit (including a CPU/monitor, medical-grade power supply and mobile cart), Field Generator stand, UroNav software and various instrumentation devices. The UroNav System Unit and the UroNav software utilize the keyboard, mouse and visual display to interact with the image data from a connected Ultrasound System. This interaction includes the selection of targets and associated navigation on the UroNav monitor. Targeted use areas for UroNav include hospital operating rooms, outpatient surgery centers, ultrasound suites, and procedure rooms. The UroNav System is designed to display the 2D live video received from commercially available ultrasound machines and use this 2D video to reconstruct a 3D ultrasound image. The system has been designed to work with the clinicians' existing ultrasound machine, transrectal ultrasound (TRUS) probe, commercially available needle guides and needle gun combinations. Additional software features include patient data management, multi-planar reconstruction, segmentation, image measurement and 3D image registration. UroNav utilizes an electromagnetic measurement system (EMMS) for identifying and tracking the location of the TRUS probe (and associated needle guides, instruments, etc.) relative to the 2D and 3D images. The EMMS Field Generator is positioned near the patient and provides an electromagnetic (EM) field for detection by a proprietary electromagnetic (EM) Sensor, which is attached to the ultrasound probe and tracks probe position while the physician performs a normal ultrasound imaging procedure of the subject prostate. The Field Generator and EM Sensor are connected to the UroNav System Control Unit and the PC running the UroNav software. Control of the ultrasound probe and ultrasound system is done manually by the physician, just as it would be in the absence of UroNav System. However, by tracking the position and orientation of the ultrasound probe while capturing the video image, UroNav System is able to reconstruct and display a 3D image and 3D rendered surface model of the prostate. The reconstructed 3D image can be further processed to perform various measurements including volume estimation and can be examined for abnormalities by the physician. Patient information, notes and images may be stored for future retrieval. Locations for biopsies, needles, markers, and other devices may be selected by the physician, displayed in the 3D image and 3D rendered surface model, and stored. Previously created 3D models may be recalled and may be aligned or registered to the current live display of the prostate. The 3D model used for co-registration may be based on another series of ultrasound images or DICOM images. The physician may also attach a commercially available biopsy needle guide to the TRUS probe and use the probe and biopsy needle to perform tissue biopsy. Whenever the ultrasound machine is turned on by the physician, the live 2D ultrasound image is displayed on the UroNav display during the biopsy. As the TRUS probe with attached needle guide is maneuvered by the physician, the position and orientation of the probe is tracked. UroNav System is able to add, display and edit plans for target locations (e.g., biopsy sites) as well as an estimate of the probe position and needle trajectory relative to the 3D image and 3D rendered surface model of the prostate and the planned target locations. UroNav System offers the physician additional 3D information for assessing prostate abnormalities, planning and implementing biopsy procedures. The additional image processing features are generated with minimal changes to previous TRUS probe based procedures, and the physician always has access to the live 2D ultrasound image during prostate assessment or biopsy procedure. In addition to standard transrectal procedures, UroNav System also supports transperineal access and commercially available gridplates normally used for performing such procedures. When using transperineal mode, the UroNav EM Sensors are attached to both the TRUS probe and the transperineal gridplate within a mechanical stepper assembly. Procedure planning, segmentation, registration and navigation are performed the same as the standard transrectal procedure except that a computer rendering of the transperineal gridplate is displayed on the UroNav System display. UroNav System provides an indication of the gridplate coordinates that correspond to the identified target location.