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The Apollo Gamma Camera System is intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel.

The Apollo Gamma Camera System offers all the features of the Forte™ Gamma Camera System (K033254) while adding the following new features: Caudal/Cephalic Imaging, a second LEHR collimator with improved sensitivity, new CHR collimator, larger Field of View (FOV) with square cornered detectors, < 3-inch brain reach, 3/4' detector crystal (in lieu of 5/8"), Automatic Body Contouring (ABC) with BodyGuard™, MegaBody Mode Imaging, 9-axis ring gantry, extra large patient bore (38" diameter), cart-based semi-automatic exchanger, optional chamfered pallet for low edge attenuation, DICOM MPPS, additional Data Management features (Audit Trail & Patient Privacy), support for new detector, and port server applications from Solaris to LINUX. Caudal/Cephalic Imaging will allow rotational "tilt" motion of at least one of the detectors about an axis of the detector (parallel to the face of the ring) of at least ±15 degrees. MegaBody mode imaging provides independent variable height positioning of the detectors which includes caudal/cephalic angulations. The detector FOV reach for brain imaging will be less than 3 inches while the detector FOV will be larger (15.5" x 21" instead of 15" x 20") due to the use of the square cornered detectors. In all these cases, the basic functionality of the detector will remain the same (as the detector in the Forte™), while adding detector flexibility to provide a better view of the heart and brain and improve image quality. The use of ¾" crystal in lieu of the 5/8" crystal for applications that require higher energy isotopes is now a common trend in the medical device industry. The ¾" crystal has higher system sensitivity (per NEMA NU-1, Section 3.8) than the 5/8" crystal. Another improvement to the system sensitivity is the use of a second type of LEHR collimator in the Apollo System. Higher system sensitivity will improve image quality and may reduce acquisition time and/or applied radiopharmaceutical dosage to the patient. A new collimator will also be used, CHR (aka Rembrandt™ Collimators) which is long-bore collimation that eliminates dead-space in the 90° corner and preserving resolution at depth. This collimator is a variation of the VXGP collimator used in the Forte™ System. The ABC mode with BodyGuard™ is an addition to the current manual mapping feature available in the Forte System. It is a refinement of the non-circular SPECT and learn-mode TB currently used in Forte™. Also, the BodyGuard™ is the sensing mechanism providing the same functionality as the Collision Avoidance feature in Forte™. The 9-axis gantry frame provides additional gantry motions designed to improve image quality. Also, the larger bore diameter provides openness for even the largest patients. The cart-based collimator exchanger uses a semi-automatic approach to simultaneously change both collimators. The chamfered pallet option is the same material and basic design as the standard pallet used for the Apollo System. It may be used in lieu of the standard pallet for certain studies that require low edge attenuation. DICOM MPPS completes the DICOM suite and is a computerized notification stating the type of study being done and when it has been completed. Audit Trail and Patient Privacy are Data Management programs to comply with HIPAA requirements. The remote desktop feature is used in the Forte™ system by remote service personnel. To enhance this feature, remote monitoring will be added to the Apollo System. The Apollo System is designed to provide extended imaging functionality relative to a ring style gantry. It is designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography (ECT) studies. The device includes the gantry frame, display panel, two detectors, a collimator storage unit, an acquisition computer unit (with an optional customer desk), a patient imaging table (includes pallet catcher), and a hand controller. The patient imaging table (pallet) is mechanized for patient loading access and for movement during imaging studies. The table may be removed by the operator for imaging of patients in wheelchairs, beds, or gurneys. The pallet includes removable arm, leg/knee, shoulder and headrest supports for patient positioning during studies that require support. The Apollo is designed to allow acquisition of a broad range of imaging studies using single or dual detectors. When using either a single detector or dual detectors placed in a relative 90-degree or relative 180-degree positions (as study appropriate). Apollo can be used to perform static, dynamic, gated, total body, circular-orbit and noncircular orbit SPECT studies, coincidence studies, gated SPECT (circular and noncircular) studies, computer-programmed protocol strings, and reference scans (dual detectors only). SPECT and total body acquisitions are routinely acquired with two detectors. There are some planar procedures such as bone statics and lung scan that also use two detectors. There are many additional nuclear medicine procedures that only use one detector at a time. These single detector procedures are typically renal. gastric emptying, hepatobiliary, flow studies, GI bleed, thyroid, and delayed static views.

JETStream® Workspace is a nuclear medicine image display and processing workstation that provides software applications used to process, analyze, and display medical images/data. The results obtained may be used as a tool, by a nuclear physician, in determining the diagnosis of patient disease conditions in various organs, tissues, and other anatomical structures. The data processed may be derived from any nuclear medicine gamma camera. The JETStream® Workspace system should only be operated by qualified healthcare professionals trained in the use of nuclear medicine equipment.

JETStream® Workspace is a Windows®-based Nuclear Medicine workstation for the Nuclear Medicine market segment. The computer system will consist of a Hewlett Packard XW4300 workstation or HP Compaq nc6230 Notebook or their equivalents. The comprehensive tools and features provided with this product, will allow the technologist and/or physician to perform image review, processing of source data, post processing, hardcopy production, interpretation, report generation and contains the utilities necessary to support the workflow and data management between those activities. The system will support connectivity aspects necessary to import and export data as required to accomplish daily work scenarios.

AutoQUANT® Plus applications are intended to enable an automated display, review, and quantification of Nuclear Medicine Cardiology medical images and datasets. AutoQUANT® Plus may be used in multiple settings including the hospital, clinic, doctors office, or remotely via dial up. The results provided should be reviewed by qualified healthcare professionals (e.g., radiologists, cardiologists, or general nuclear medicine physicians) trained in the use of medical imaging devices.

AutoQUANT® Plus (K040326) was composed of the following applications: AutoQUANT® (K040326) [AutoOUANT integrates 2 functionalities, Quantitative Perfusion SPECT (QPS) and Quantitative Gated SPECT (QGS) into a single application for LV (Left Ventricle) extraction and analysis], Quantitative Blood Pool SPECT (QBS) and optionally QARG (for reporting purposes). The modified AutoQUANT® Plus is a suite of applications for the processing and review of Cardiac SPECT and PET datasets. AutoQUANT® Plus is composed of the following applications: AutoQUANT® (K040326) [AutoQUANT integrates 2 functionalities, Quantitative Perfusion SPECT (QPS) and Quantitative Gated SPECT (QGS) into a single application for LV (Left Ventricle) extraction and analysis). AutoQUANT Plus will be marketed as AutoQUANT NM, which combines the following two separate sets of functionality: AutoQUANT - optimized for SPECT studies and OPET - optimized for PET studies. Both sets of functionality offer a comprehensive application suite that includes QGS (Quantitative Gated SPECT) and OPS (Quantitative Perfusion SPECT) applications. This allows automatic processing and review of quantitative and qualitative information generated by nuclear medicine studies. QPET also includes viability quantification and two additional databases (rubidium and ammonia) for processing PET studies. AutoQUANT NM can also be purchases separately as AutoOUANT (for SPECT study data) or QPET (for PET study data). Purchasable Options consist of Quantitative Blood Pool SPECT (QBS), QARG (for reporting purposes), Fusion (SPECT/CT/CTA and/or PET/CT/CTA, and Prone-Supine (Prone+) for SPECT studies. AutoQUANT® is a software application designed to enable an automated, comprehensive review and quantification of Cardiac SPECT data. AutoQUANT® integrates 2 functionalities, Quantitative Perfusion SPECT (OPS) and Quantitative Gated SPECT (QGS) into a single application for LV (Left Ventricle) extraction and analysis. AutoQUANT® provides a tool to review and quantify all types of Cardiac SPECT data sets (perfusion and/or gated) to determine the location, orientation, and anatomical extent of the left ventricle of the heart, to construct 3D contour maps of the heart, and to calculate the heart volume (for the left ventricular wall), the lung/heart ratio, and transient ischemic dilation (TID). Physicians use this information to assess the anatomical and physiological functionality of the heart and analyze the presence of myocardial defects through comprehensive imaging modalities. A new Phase toggle on the OGS page gives access to phase information for gated datasets. Stress-Rest Registration is a direct method for detecting changes between stress and rest images. It is a practical and fully automatic algorithm for quantification of stress-induced changed from paired stress and rest scans and does not use protocol-specific databases. A new technique to create cardiac "motionfrozen" perfusion or viability images, by warping ECG-gated images to the end-diastolic position has been added. Such "motion-frozen" perfusion and viability images have improved resolution and contrast by removing blurring effect caused by cardiac motion. Prone-supine quantification allows quantification of perfusion on prone images as well as combined quantification of prone/supine datasets by applying heuristic rules, which allow automatic elimination of image artifacts based on the relative defect locations on prone and supine images. The new shape index parameter defines 3D left ventricular (LV) geometry derived from LV contours in end systolic and end diastolic phases. The AutoQUANT application provides Normal Files database for stress, rest, and gender criteria for Dual Isotope and Mibi (Te-Sestamibi): The new version of QPS includes the simplified algorithm for the quantification of myocardial perfusion, using normal limits created from studies of low-likelihood normal patients only. The new algorithm has been validated in a large group of patients demonstrating equivalent diagnostic performance despite the use of simplified normal limits. In addition, to Dual Isotope and Mibi Mibi using the new simplified algorithm, the following additional databases are being provided Vantage MibiMibi, Thallium Stress/Rest, Astonish ½ Time Dual, and Astonish ½ Time Mibi. Optional Normals databases offered are Rubidium for PET, Ammonia for PET. QPS provides the ability for User Generated Normal Files using the simplified method. The new version of QPS also includes a new variable, Total Perfusion Deficit (TPD), which combines defect extent and severity values. For backward compatibility reasons, the old QPS perfusion quantification method, which displays individual defect extent and severity values, can be accessed by checking off PFQ option in the QPS Application Defaults. All the functional QGS values (ejection fraction, LV volumes etc) and contour definitions are the same as before. Quantitative Blood Pool SPECT (QBS) is an optional application. QBS is an interactive standalone software application for the automatic segmentation and quantification of gated short axis blood pool (red blood cells, RBC) SPECT. The application can be used for automatic generation of left and right ventricular endocardial surfaces and valve planes from three-dimensional (3D) gated short axis blood pool images; automatic calculation of left and right ventricular volumes and ejection fractions; calculation and display of polar maps representing wall motion and parametric values (FFH amplitude and phase); twodimensional (2D) image display using standard American College of Cardiology (ACC) cardiac SPECT conventions; and 3D image display. It also provides the following functionalities: ability to combine isosurfaces extracted from the data with the calculated endocardial surfaces in various ways (endocardial borders displayed as wireframes, shaded surfaces, both, or parametric); ability to man parametric values (First Fourier Harmonic (FFH) amplitude and phase) on the surfaces; ability to display parametric images (FFH amplitude and phase) for gated planar, gated raw projections and gated short axis images; ability to display cine loops of the original images; ability to generate count-based quantitative values using the automatically- and semi automatically-computed surfaces as ROIs and user-selectable thresholds; ability to generate and display phase histograms for FFH phase images and to display the mean and standard deviation of the peaks corresponding to atrial and ventricular voxels. After ventricular segmentation, a phase histogram for each ventricle is also computed and displayed; and ability to display normalized images for all gated images (i.e., images that do not exhibit count drop-off caused by arrhythmia). In addition, QBS supports manual identification of the leftventricular (LV) region, to separate it from the right ventricle (RV) in cases where the automatic algorithm fails or returns unsatisfactory results; ability to generate filling rates from interpolated time-volume curves; and the ability to rotate, zoom, and cine surfaces. The ability to load and display PET, CT, CTA datasets in AutoQUANT® Plus have been added as an option. Qualitative displays are now provided functional PET data and CT/CTA anatomical datasets. In addition, nuclear image fusion package has been added for both SPECT/CT and PET/CT hybrid applications. A SPECT/CT fusion package including SPECT/CT/CTA Fusion Page, that allows for display of segmented and labeled coronary vessels with perfusion SPECT 3D data. A PET/CT fusion package including PET/CT/CTA Fusion Page, that allows for display of segmented and labeled coronary vessels with PET 3D data. Functionality includes orthogonal planes using alpha blending. roving window and synchronized cursor. It allows users to perform quality control of SPECT/CT/CTA or PET/CT/CTA alignment and has generic multimodality fusion capabilities. This feature provides display of fused images in a visual format. Additionally, included for PET analysis is the Hibernating Myocardium Assessment (mismatch and viability); This module allows quantitative assessment of "hibernating myocardium" by quantification of changes between PET perfusion and viability images in hypo-perfused area. Scar and Mismatch parameters are reported as a percentage of the Left Ventricle and are displayed in polar coordinates or a 3D surface display.

Precedence is an imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed tomography system. The x-ray computed tomography subsystems may consist of a whole body multi-slice CT or cardiovascular CT. The cardiovascular subsystem provides coronary imaging that is intended to produce cross-sectional images of the heart, cardiovascular, and peripheral vascular systems by computer reconstruction of x-ray transmission data taken at difference angles and planes. Precedence may produce non-attenuation corrected and attenuation corrected images of the distribution of radiopharmaceuticals in the body as well as x-ray transmission images. The CT transmission data may be used to produce attenuation corrected nuclear medicine images. The nuclear medicine images and the CT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide combined single photon and anatomical data for anatomical localization of the nuclear medicine data. Precedence may be used either as a separate single photon system, a separate CT system or as a combined CT and single photon system. The nuclear medicine and CT images may be transferred to other systems such as a radiation therapy planning system. The Precedence Imaging System should only be used by trained healthcare professionals. The Precedence CV Configuration CT subsystem is only for the imaging of the cardiovascular system.

The Precedence SPECT/CT Imaging System is a hybrid SPECT/CT system for performing CT studies, general nuclear medicine studies, or SPECT/CT sequentially (dual-modality studies) wherein the SPECT and CT studies may be automatically coregistered and displayed in fused form. Because the natures of the imaging modalities, they provide different information; the SPECT study yields functional information about metabolic processes and the CT study yields structural or anatomical information. As radionuclides become more tissue specific, diagnoses from nuclear images alone will be more difficult without the general anatomical detail less specific agents provide. Thus fused SPECT and CT images will provide the information required for accurate and comprehensive diagnoses. Precedence is constructed from two existing systems, the Skylight SPECT Imaging System and the Brilliance CT with subsystem options of 6, 16, or 64 slice or the CVCT configuration. The Precedence has two acquisition consoles. One console is placed in the acquisition room itself, consistent with the SPECT convention, and the other console is placed in the shielded scanner control room, as required for CT. The acquisition stations provide a single user interface for both SPECT and CT patient acquisition set-up. The SK Ylight and Brilliance system gantries remain intact as major subsystem components located within a common integrated housing. The combined Precedence SPECT-CT Imaging System is designed so that the system can operate in three modes: CT only, SPECT only, and combined SPECT/CT performed sequentially. No modifications have been made to either system, which would affect system performance. Precedence is intended for use primarily as an imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed tomography system. The clinical protocols and procedures are that are available on the modified Precedence Imaging System are the same as those on the Predicate Devices Precedence SPECT/CT (cleared as Griffin) (K041218), Predicate Philips Plus CT Scanner (K033326), and the Brilliance CT, Private Practice CV configuration CT Scanner (K042293). The intended use of the CV configuration CT Scanner is limited to the heart, cardiovascular, and peripheral vascular systems. Acquired SPECT and CT images on the Precedence may be registered and displayed in a fused format (overlaid in the same orientation) to provide combined single photon and anatomical data to provide anatomical localization of the nuclear medicine image. The Precedence CV Configuration CT subsystem is not indicated for imaging structures that are defined as non-cardiac and non-vascular (including soft tissue and bone).

AutoSPECT® produces images, which depict the three-dimensional distribution of radiopharmaceutical tracers in a patient. This software is intended to provide enhancements to gamma camera emission image processing by automating previously manual image processing functions, providing manual and automated motion correction, providing enhanced reconstruction algorithms that include resolution recovery, scatter correction, noise compensation, and attenuation correction via application of a transmission dataset.

AutoSPECT is a software application that produces images, which depict the threedimensional distribution of radiopharmaceutical tracers in a patient via automatic or manual processing. One or more cardiac SPECT, gated SPECT, or MCD cardiac data sets may be processed automatically using AutoSPECT. Additionally, one or more non-cardiac SPECT, gated SPECT, or MCD data sets may be processed manually. AutoSPECT contains basic data-processing algorithms that have been cleared previously; in addition to enhanced data reconstruction algorithms that include scatter correction, resolution recovery, map-based attenuation correction, and OSEM (Astonish SPECT) reconstruction. The AutoSPECT software option may be used on images from a gamma camera system that are DICOM 3.0 compatible. The following data sets may be used: - Cardiac, brain, or other (bone, liver, etc.) SPECT datascts . - . Gated SPECT datasets - . Vantage SPECT datasets - SPECT-CT datasets . - Total Body SPECT datasets - MCD and MCD-AC datasets . AutoSPECT provides the user three options for automatically processing cardiac datasets: AutoAll, Auto Recon, and Auto Reorient. Each option is described in greater detail in the software description section. AutoSPECT also allows the user to process non-cardiac SPECT and MCD datasets. In this case, the operator manually positions the reconstruction limit lines to reconstruct transverse data sets. If necessary, the data set can be reoriented manually by positioning the azimuth, elevation, and twist lines to the desired locations. In addition, the capability of processing groups of SPECT data sets in a batch mode fashion is provided. Once the operator has selected the datasets and determined the processing method, AutoSPECT processes the first dataset, followed by all remaining datasets without further interaction from the user. AutoSPECT application runs on Microsoft Windows XP Professional environment. The minimum hardware requirements is listed: - . Intel x86/Pentium class processor > 1 GHz ; - Graphics capability must meet or exceed 1280x1024 pixels with 32 bit pixel . depth; - . 30 Gb of disk space (minimum); - . 512 Mb of DRAM (minimum); - . 10/100 BaseTX Ethernet interface; - . Port capable of supporting a dongle; - . CD drive- capable of reading and writing: - 56Kbps modem (minimum) .

Pinnacle3 Radiation Therapy Planning System is a computer software package intended to provide support for radiation therapy treatment planning for the treatment of benign or malignant disease processes. Pinnacle3 Radiation Therapy Planning System assists the clinician in formulating a treatment plan that maximizes the dose to the treatment volume while minimizing the dose to the surrounding normal tissues. The system is capable of operating in both the forward planning and inverse planning modes. The device is indicated for use in patients deemed to be acceptable candidates for radiation treatment in the judgment of the clinician responsible for patient care. Plans generated using this system are used in the determination of the course of a patient's radiation treatment. They are to be evaluated, modified and implemented by qualified medical personnel.

Pinnacle3 Radiation Therapy Planning System version 7.2 (hereafter Pinnacle' RTP) provides radiation therapy planning for the treatment of benign or malignant diseases. When using Pinnacle3 RTP, qualified medical personnel may generate, review, verify, approve, print and export the radiation therapy plan prior to patient treatment. Pinnacle RTP can approvide plans for various radiation therapy modalities including External Beam Treatment, Stereotactic Radiosurgery, and Brachytherapy. Pinnacle3 RTP is a software package that runs on a Sun UNIX (or UNIX compliant) computer and consists of a core software module (Pinnacle') and optional software features. These optional software features, commonly referred to as "plug-ins", are typically distributed separate from the core software product (separate CD-ROM). The device has network capability to other Pinnacle RTP workstations and to both input and output devices via local area network (LAN) or wide area network (WAN). Image data is imported from CT, MR, PET, PET-CT and SPECT devices using a DICOMmage atta interface. A qualified medical professional uses the Pinnacles RTP for functions such as viewing and analyzing the patient's anatomy, and generating a radiation therapy plan. The viowing and analyzing are examples of tasks that may be performed by clinicians when using the Pinnacle' RTP system: - Evaluate the treatment plan based on radiation-sensitive structures and the tumor. ◆ - Combine both geometric and dosimetric planning on the same platform, including CT . simulation data and plans. The CT simulation parts of the system are called AcQSim² and Simulation. - Configure beam variables such as energy, geometry, and beam modifiers such as blocks, . wedges, multi-leaf collimators, bolus and compensators. - Visualize the beam on a display, initiate the dose computation, and set the weight of each . beam. - Obtain dose measurements from any Points of Interest (POI). . - Perform photon and electron physics modeling, dose algorithm and machine ● commissioning. This functionality is supported by the Physics Utility Module. - Evaluate images away from the workstation via a laptop or physician group workstation. . The feature that provides remote review is referred to as P3MD. - Create data for use in conjunction with treatment QA systems. . - Configure, backup, archive, restore, and scripting. . - Evaluate Digitally Reconstructed Radiographs (DRRs) on Pinnacle RTP or remote system . using DICOM Secondary Capture (SC) Export. Once complete, Pinnacle3 RTP has the ability to transfer the finished plan to other devices used in Onec comprete, I minute - Record and Verify, Linear Accelerator (Linac) Workstations and/or 310 Party QA systems. The following Pinnacle³ RTP features are also available to assist the clinician with the radiation therapy planning process. These features are distributed on standalone CD-ROM media, and installed onto the Pinnacle' RTP workstation. Corresponding instructions for use such as User Guides or Release Notes are also provided to the clinician for each optional feature. P3IMRT (Intensity Modulated Radiation Therapy): P INKT (Incentines both forward and inverse planning functionality. The system determines a plan that satisfies the user's treatment goals through an optimization process. The user's treatment goals are specified as objectives and constraints based on dose distribution characteristics. Syntegra (also referred to as AutoFusion): Syntegra (utomates multi-modality image registration and fusion by overlaying images from CT, MR, PET, PET-CT and SPECT devices using a DICOM-compliant interface. This feature provides clinicians with the ability to relate, interpret and contour an image's anatomic and functional information. In addition to the above, the following software options are available to facilitate image and/or data import and export between radiation therapy devices such as the imaging camera, Pinnacle' RTP, and Record & Verify system. DICOM is the acronym for Digital Imaging and Communications in Medicine and is an internationally recognized standard for transferring biomedical information such as images and data between devices or over a network. DICOM RT: DICOM RT software is used to support both Structure Set and Radiation Therapy Plan import and export functions. Structure Sets describe regions and points of interest to other systems. Plan information includes beam geometry and delivery information. DICOM Image: DICOM Image software is used to support image import and export to and from the Pinnacle RTP workstation according to the NEMA DICOM standard, version 3.0. This functionality allows diagnostic imaging devices supporting the DICOM 3.0 standard to interface with the Pinnacle system. Mitsubishi DME: A proprietary interface has been created within the Pinnacles Treatment Planning System to support plan export to Mitsubishi Record and Verify systems. This interface is called the "Mitsubishi DME" system. This is implemented as a simple file based interface according to a format specified by Mitsubishi. P3 MD: P3MD allows for treatment plan review and minor alternations by a physician from a PC-based workstation that is connected to the same network as the primary Pinnacle Treatment Planning workstation.

Griffin is an imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed tomography system. Griffin may produce non-attenuation corrected and attenuation corrected images of the distribution of radiopharmaceuticals in the body as well as x-ray transmission images. The CT transmission data may be used to produce attenuation corrected nuclear medicine images. The nuclear medicine images and the CT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide combined single photon and anatomical data for anatomical localization of the nuclear medicine data. Griffin may be used either as a separate single photon system, a separate CT system or as a combined CT and single photon system. The nuclear medicine and CT images may be transferred to other systems such as a radiation therapy planning system. The Griffin Imaging System should only be used by trained healthcare professionals.

The Griffin SPECT/CT Imaging System (Griffin) is a hybrid SPECT/CT system for performing CT studies, general nuclear medicine studies, or SPECT/CT scquentially (dual-modality studies) wherein the SPECT and CT studies may be automatically co-registered and displayed in fused form. Because the natures of the imaging modalities, they provide different information; the SPECT study yields functional information about metabolic processes and the CT study yields structural or anatomical information. As radionuctides become more tissue specific, diagnoses from nuclear images alone will be more difficult without the general anatomical detail less specific agents provide. Thus fused SPECT and CT images will provide the information required for accurate and comprehensive diagnoses. Griffin is constructed from two existing systems, the Skylight Imaging System (K031705) and the Brilliance CT (K012009). The Griffin has two acquisition consoles. One console is placed in the acquisition room itself, consistent with the SPECT convention, and the other console is placed in the shielded scanner control room, as required for CT. The acquisition stations provide a single user interface for both SPECT and CT patient acquisition set-up. The SK Ylight and Brilliance system gantries remain intact as major subsystem components located within a common integrated housing. The combined Griffin SPECT-CT Imaging System is designed so that the system can operate in three modes: CT only, SPECT only, and combined SPECT/CT performed sequentially. No modifications have been made to either system, which would affect system performance. Griffin is intended for use primarily as an imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed tomography system. The same clinical protocols and procedures are available on the Griffin Imaging System as in the predicate SPECT or CT systems. Acquired SPECT and CT images on the Griffin may be registered and displayed in a fused format (overlaid in the same orientation) to provide combined single photon and anatomical data to provide anatomical localization of the nuclear medicine image.

Syntegra™ is a software application for multi-modality image registration and diagnostic fusion. Images are registered and displayed in a "fused" (overlaid in the same spatial orientation) format to provide combined functional and anatomical data providing different angular perspectives for interpretation by trained professionals

Syntegra™ is a software application for multi-modality image registration and diagnostic fusion. This application exists within the predicate device, Gemini 16 (K032036). The Gemini 16 is an imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT). This PET/CT device includes the processing station and applications contained within, such as image fusion. Syntegra™ may be offered as a standalone software application that has the capability to be utilized on any PC image processing workstations meeting the minimum hardware requirements to support the application. Registration is the process of aligning two or more images from the same patient so that physical positions within each image are coincident. The images may be from the same imaging modality or different imaging modalities. Fusion display is the visual combination of two image data sets that allows the data sets to be displayed simultaneously in a blended mode in the same screen window. The level of be arejected by user adjustable opacity values assigned to each data set. A common application of fusion display is the combination of physiological data from SPECT images and anatomical information from CT images. Images are registered and displayed in a fused format to provide combined functional and anatomical data. The images are presented using various three-dimensional rendering techniques such as multi-planar reformatting, surface rendering with cut-planes, and maximum intensity projections. Syntegra also offers Region of Interest tools. These are tools, which allow a user to draw two-dimensional contours around areas of interest on the transaxial image planes. The contours may then be exported to Radiation Therapy Planning systems, which use the two dimensional contours to generate three-dimensional volumes, which may be used in therapy planning. The application operates on WindowXP/Intel Pentium computer systems with the following minimum requirements: - Graphics Card: 24/32 bit color, support for 1400x1162 screen resolution . - RAM: 1 GB . - Processor: Pentium IV and above . - Clock Speed: 1GHz clock speed .

AutoQUANT® Plus applications are intended to enable an automated display, review, and quantification of Nuclear Medicine Cardiology medical images and datasets. AutoOUANT® Plus may be used in multiple settings including the hospital, clinic, doctors office, or remotely via dial up. The results provided should be reviewed by qualified healthcare professionals (e.g., radiologists, cardiologists, or general nuclear medicine physicians) trained in the use of medical imaging devices.

AutoQUANT® Plus is a suite of applications for the processing and review of Cardiac SPECT and blood pool SPECT datasets. AutoOUANT® Plus is composed of the following applications: AutoQUANT® (K980715) [AutoQUANT integrates 2 functionalities, Quantitative Perfusion SPECT (QPS) and Quantitative Gated SPECT (QGS) into a single application for LV (Left Ventricle) extraction and analysis], Quantitative Blood Pool SPECT (QBS) (K022428), and optionally QARG (for reporting purposes). Previously, the marketing clearance for QBS (K022428) was scparate and is now being combined with the AutoOUANT Plus 510(k) being submitted. AutoQUANT® is a software application designed to enable an automated, comprehensive review and quantification of Cardiac SPECT data. AutoQUANT® integrates 2 functionalities, Quantitative Perfusion SPECT (OPS) and Quantitative Gated SPECT (QGS) into a single application for LV (Left Ventricle) extraction and analysis. AutoQUANT® provides a tool to review and quantify all types of Cardiac SPECT data sets (perfusion and/or gated) to determine the location, orientation, and anatomical extent of the left ventricle of the heart, to construct 3D contour maps of the heart, and to calculate the heart volume (for the left ventricular wall), the lung/heart ratio, and transient ischemic dilation (TID). Physicians use this information to assess the anatomical and physiological functionality of the heart and analyze the presence of myocardial defects through comprehensive imaging modalities. Also included in AutoQUANT Plus is Quantitative Blood Pool SPECT (QBS). OBS is an interactive standalone software application for the automatic segmentation and quantification of gated short axis blood pool (red blood cells, RBC) SPECT. The application can be used for automatic generation of left and right ventricular endocardial surfaces and valve planes from three-dimensional (3D) gated short axis blood pool images; automatic calculation of left and right ventricular volumes and ejection fractions; calculation and display of polar maps representing wall motion and parametric values (FFH amplitude and phase); two-dimensional (2D) image display using standard American College of Cardiology (ACC) cardiac SPECT conventions; and 3D image display. It also provides the following functionalities: ability to combine isosurfaces extracted from the data with the calculated endocardial surfaces in various ways (endocardial borders displayed as wireframes, shaded surfaces, both, or parametric); ability to map parametric values (First Fourier Harmonic (FFH) amplitude and phase) on the surfaces; ability to display parametric images (FFH amplitude and phase) for gated planar, gated raw projections and gated short axis images; ability to display cine loops of the original images; ability to generate count-based quantitative values using the automatically- and semi automatically-computed surfaces as ROIs and user-selectable thresholds; ability to generate and display phase histograms for FFH phase images and to display the mean and standard deviation of the peaks corresponding to atrial and ventricular voxels. After ventricular segmentation, a phase histogram for each ventricle is also computed and displayed; and ability to display normalized images for all gated images (i.e., images that do not exhibit count drop-off caused by arrhythmia). In addition, QBS supports manual identification of the left-ventricular (LV) region, to separate it from the right ventricle (RV) in cases where the automatic algorithm fails or returns unsatisfactory results; ability to generate filling rates from interpolated time-volume curves; and the ability to rotate, zoom, and cine surfaces. In addition, an automatic report generation (ARG) feature has been added to AutoQUANT® Plus. This option in AutoOUANT produces consistent PDF (or text) reports based on a series of form elements within AutoQUANT . The tool consists of an additional window within AutoQUANT and does not alter any quantitative values. This is designed to reduce transcription errors and automate workflow. A separate QARG application allows searching and management of the ARG database, which requires all data to be manually entered. There are no algorithmic functions within the ARG/QARG feature.