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The CPS LSO PET/CT HiRez Series Scanners are combined positron emission tomography (PET) and X-ray computed tomography (CT) scannesr. The LSO PET/CT scanner is intended to be utilized by appropriately trained health care professionals to 1) image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body, and 2) to produce cross-sectional images of the body by computer reconstruction of x-ray prounds sion data from either the same axial plane taken at different angles or spiral planes* taken at different angles. The PET and the CT functions of this system can also be used in combination to provide high resolution, noise free CT attenuation correction maps for PET images and, additionally, utilized to produce fused CT and PET images, providing detailed anatomic and metabolic function information in a single image. (*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube and the simultaneous translation of the patient.)

The CPS LSO PET/CT Hi-Rez series of scanners are combined Positron Emission Tomography and X-Ray Computed Tomography scanners. These systems are designed for whole-body oncology, neurology and cardiology syotome are a signiture registration and fusion of high-resolution metabolic and anatomic information from the two major components of each system, the and anatomic informanner and the Siemens Somatom CT (either Emotion or Sensation depending on the specific model). The combined PET/CT scanner is intended for use as a clinical, whole-body oncology machine with high-end spiral CT and PET performance. The CT oncology maonine mans, quiet attenuation correction for PET studies as well as oomponont provided farmer through fused PET and CT images. In addition, the PET / CT system maintains independent functionality of the PET and CT scanning systems, allowing for most standard stand-alone CT and PET clinical diagnostic protocols to be available as well. Changes incorporated in this system are the result of a cost reduction effort Changes incorporated in this System are the roomtry to be modified easily. combined with changes that allow the "look" of the gantry to be interest Combined with chunges that and rain and and acturability and Adultional changes were intorporation to inipes were . These changes were serviceability as well as to deal with parts obsolescence. (RUC) The City Serviceability as well as to deal with parts esset Handling System (PHS). The CT limited to the PET gantry as well as the Patient Handling System (PHS). The CT illined to the F LT gamry as well as the reviously commercially available systems.

The CPS LSO PET/CT HiRez 64 system is a combined position emission tomography (PET) and X-ray computed tomography (CT) scanner. The LSO PET/CT scanner is intended to be utilized by appropriately trained health care professionals to 1) image and measure the distribution of injected position emitting radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body; and 2) to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles. The PET and the CT functions of this system can also be used in combination to provide high resolution, noise free CT attenuation correction maps for PET images and, additionally, utilized to produce fused CT and PET images, providing detailed anatomic and metabolic function information in a single image. (*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube and the simultaneous translation of the patient.)

The CPS LSO PET/CT Hi-Rez 64 system is a combined Positron Emission Tomography and X-Ray Computed Tomography scanner. The system is an addition to the current CPS PET/CT Hi-Rez Family of PET/CT systems and is essentially identical to the commercially available CPS LSO PET / CT Hi-Rez 16 system (K033431) with the exception of a higher resolution CT system -Siemens 64 slice CT (K040665). The system is designed for whole-body oncology, neurology and cardiology examinations. The PET / CT 64 gantry system consists of a separate PET and CT gantry that retain their independent scanning mechanisms, including mechanical and electrical components. In addition, it provides registration and fusion of high-resolution metabolic and anatomic information from the two major components of the system, the Accel Hi-Rez LSO PET scanner and the Siemens Somatom Sensation 64 CT. The difference between the current Sjemens Sensation 16 used in the commercially available CPS PET/CT systems is the number of slices acquired per rotation. Current PET/CT's are capable of acquiring 16 slices per rotation while the Sensation 64 is capable of acquiring 64 slices per rotation, thus increasing the resolution of the acquired CT scan.

The CTI PET Systems Inc. ECAT HRRT positron emission tomography (PET) scanners are intended to be utilized by appropriately trained health care professionals to image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic and physiologic functions within the human body.

The CTI PET Systems ECAT HRRT is a new positron emission tomography (PET) scanner system. The ECAT HRRT PET scanners utilize flat panel detector heads, combined LSO (Lutetium Oxyortho-Silicate) / LYSO (Lutetium Yttrium Oxyortho-Silicate) crystal detector technology. The HRRT consists of eight detector panels in an octagonal arrangement completely encircling the bore of the Gantry. A Patient Handling System (PHS) will be offered as an optional accessory with the scanner. This PHS is similar to other PHS systems currently marketed with the exception that it has been specifically designed for use with the HRRT. Modifications have been made to accommodate the different size gantry bore and shorter horizontal travel associated with this gantry. The acquisition computer system is comprised of an Intel based acquisition PC, a Raid system disk and a console connected via fibre channel to the HRRT electronics. This is the same as is used in the ECAT ACCEL (K002584) with the exception of the RAID disk. Software is based on the Standard ECAT software (7.x), which is used with the ECAT ACCEL system. Modifications have been made to accommodate the new acquisition system, enlarged data sets (due to increased resolution) and user interface to allow clinician flexibility in reconstruction.

The LSO PET/CT Hi Rez and LSO PET/CT 16 HiRez tomographic scanner systems are combined positron emission tomography (PET) and X-ray computed tomography (CT) scanners. The LSO PET/CT Hi Rez and LSO PET/CT 16 HiRez scanners are intended to be utilized by appropriately trained health care professionals to 1) image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body; and 2) to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles. The PET and the CT functions of this system can also be used in combination to provide high resolution, noise free CT attenuation correction maps for PET images and, additionally, utilized to produce fused CT and PET images, providing detailed anatomic and metabolic function information in a single image. (*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube and the simultaneous translation of the patient.)

The LSO PET/CT HiRez is a family of combined positron emission tomography (PET) and X-ray computed tomography (CT) scanners. These dual modality tomographs are modified versions of the ECAT LSO PET/CT (K013504) and ECAT LSO PET/CT 16 (K023518) and will utilize the same Siemens SOMATOM CT scanner components as their respective predicate PET/CT scanners. However, on this new family of CPS PET/CT HiRez systems, the ACCEL PET scanner electronics has been modified to appreciably increase PET count rate capability, with front-end acquisition electronics processing speed being significantly improved. The modified ACCEL PET scanner component will also incorporate a new version block detector utilizing a 13 by 13 LSO crystal matrix in place of the previously used 8 by 8 LSO crystal matrix which will provide a significant improvement in the spatial resolution of PET images. As with the predicate systems, 2D PET acquisition septa and PET transmission sources are not included in the modified LSO PET/CT HiRez systems. PET emission data are acquired only in 3D and PET attenuation correction map data are obtained from the CT. The PET and CT components of each system are contained within a unified housing similar to the predicate ECAT LSO PET/CT and ECAT LSO PET/CT 16 scanners to create an integrated PET, CT and combined PET/CT, tomographic imaging system. The outward appearance of this family of modified PET/CT HiRez systems remains the same as the similarly configured preceding models. The LSO PET/CT HiRez gantry structure, patient handling system (PHS), advanced computational system (ACS 3) and workstation will be the same as those used with the LSO PET/CT and ECAT LSO PET/CT 16 systems. Software used in these scanners will be the most recent version of the previously used PET/syngo software with minor changes to accommodate the revised PET acquisition electronics and modified crystal configuration detectors. User operating instructions have been revised accordingly. The LSO PET/CT HiRez scanners are intended for use primarily as clinical, whole-body oncology machines with medium to high-end spiral CT performance and fast patient-throughput clinical PET performance. As on the predicate systems, the CT component will also enhance PET scans by allowing fast, essentially noise-free attenuation correction for PET studies, and by providing precise anatomical reference through fused PET and CT images. In addition, the LSO PET/CT HiRez scanners will retain mechanical isolation and independent functionality of the PET and CT scanning systems, thereby allowing for most standard CT and PET clinical diagnostic protocols to be available on these PET/CT systems. The purpose of introducing this family of modified LSO PET/CT HiRez tomographic systems is to offer a series of PET/CT scanners having a varied range of CT performance combined with the fast patient throughput of the modified ACCEL PET, as an even higher performance alternative to the presently distributed ECAT LSO PET/CT and ECAT LSO PET/CT 16 PET/CT systems.

The PET/CT Patient Handling System (PHS) is a system component of CPS ECAT PET/CT tomographic scanner systems, which are combined positron emission tomography (PET) and X-ray computed tomography (CT) scanners. The PET/CT Patient Handling System is used to support and move a patient through the PET/CT scanner while CT and PET diagnostic image data are being acquired from the patient. The ECAT PET/CT scanners are intended to be utilized by appropriately trained health care professionals to 1) image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body; and 2) to produce crosssectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles. The PET and the CT functions of these systems can also be used in combination to provide high resolution, noise free CT attenuation correction maps for PET images and, additionally, utilized to produce fused CT and PET images, providing detailed anatomic and metabolic function information in a single image.

The subject device is the patient handling system (PHS) or patient bed that is used with the currently marketed CPS ECAT PET/CT scanners. The ECAT PET/CT, ECAT LSO PET/CT and ECAT LSO PET/CT 16 systems are combined position tomography (PET) and X-ray computed tomography (CT) scanners. These three dual modality PET/CT tomographs all utilize the same basic patient handling system (PHS) to support and move the patient through the patient port in the scanner gantry. Currently, vertical positioning of the patient on the bed of these PET/CT scanners is only possible when the PHS bed is fully retracted out of the patient port. The proposed modification for the PHS used on these three PET/CT scanners, which consists of two added footswitches and revised PHS controller firmware, will enable the system operator to raise or lower the PHS bed a limited distance when the bed and patient are in the scanner field of view (FOV), inside the patient port. This modification will allow the operator to more accurately position the patient in the FOV without having to first retract the bed and patient completely out of the patient port.

The ECAT LSO PET/CT 16 tomographic scanner system is a combined positron emission tomography (PET) and X-ray computed tomography (CT) scanner. The ECAT LSO PET/CT 16 scanner is intended to be utilized by appropriately trained health care professionals to 1) image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body; and 2) to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles. The PET and the CT functions of this system can also be used in combination to provide high resolution, noise free CT attenuation correction maps for PET images and, additionally, utilized to produce fused CT and PET images, providing detailed anatomic and metabolic function information in a single image. (*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube and the simultaneous translation of the patient.)

The ECAT LSO PET/CT 16 is a combined positron emission tomography (PET) and X-ray computed tomography (CT) scanner. This dual modality tomograph is a modified version of the ECAT LSO PET/CT (K013504) and will utilize the same PET component as the ECAT LSO PET/CT scanner. However, in place of the Siemens P10 SOMATOM EMOTION CT component that uses a single or dual row of X-Ray detectors, the ECAT LSO PET/CT 16 will be configured with the Siemens P30 SOMATOM SENSATION CT, utilizing 24 rows of X-Ray detectors and having the capability to acquire 16 slices of X-Ray data simultaneously. As with the unmodified system, 2D PET acquisition septa and the PET transmission sources are not incorporated in the modified ECAT LSO PET/CT. PET emission data is acquired only in 3D mode and PET attenuation correction map data are obtained from the CT. The PET and CT components are contained within a unified housing similar to the original ECAT LSO PET/CT to create an integrated, PET, CT, and combined PET/CT, tomographic imaging system. The ECAT LSO PET/CT 16 gantry structure, patient handling system (PHS), advanced computational system (ACS 3), workstation and software will be similar to the ECAT LSO PET/CT with only minor modifications. The gantry's unified housing has been modified cosmetically and enlarged to accommodate the increased size of the SOMATOM P30 CT gantry. In addition, the patient handling system (PHS) has been modified to ensure adequate dual scan coverage for PET and CT patient scanning, with the increased axial depth of the new SOMATOM P30 CT gantry. The high performance Siemens P30 SOMATOM SENSATION CT with 16 slice capability provides for faster and higher quality CT acquisitions but does not otherwise affect performance of the ECAT LSO PET/CT 16. The ECAT LSO PET/CT 16 scanner is intended for use primarily as a clinical, whole-body oncology machine with high-end spiral CT performance and fast patient-throughput clinical PET performance. As on the original system, the CT component will also enhance PET scans by allowing fast, essentially noise-free, attenuation correction for PET studies and by providing precise anatomical reference through fused PET and CT images. In addition, the ECAT LSO PET/CT 16 will retain mechanical isolation and independent functionality of the PET and CT scanning systems, thereby allowing for most standard CT and PET clinical diagnostic protocols to be available on the PET/CT system. The purpose of introducing this modified ECAT LSO PET/CT 16 system is to offer a combined PET and CT tomograph having very high CT performance with the fast throughput of the ECAT ACCEL PET, as a higher performance alternative to the presently distributed ECAT LSO PET/CT system.

The CPS/Siemens ECAT Vision 3000 and Vision 5000 PET systems are positron emission tomography (PET) scanners that are intended to be utilized by appropriately trained health care professionals to image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic and physiologic functions within the human body. CPS ECAT Vision 3000 and ECAT Vision 5000 positron emission tomography (PET) scanners are intended to be utilized by appropriately trained health care professionals to detect the location and distribution of injected positron-emitting radionuclides in the body and produce cross- sectional images through computer reconstruction of the data.

The ECAT Vision 3000 and Vision 5000 are new positron emission tomography (PET) scanner systems. The ECAT Vision series PET scanners utilize rotating flat panel detector heads, LSO crystal detector technology and coincidence point source transmission scan capability. The ECAT Vision series scanners are produced and marketed under two distinct models, the ECAT Vision 3000 and the ECAT Vision 5000. The two models of the ECAT Vision are configured with either: 1) three detector heads in the ECAT Vision 3000, or 2) five detector heads in the ECAT Vision 5000. A Patient Handling System (PHS) is provided with the Vision series scanners, which is a slightly modified version of the PHS included with the CPS ECAT EXACT series PET scanners (K962797). Vertical bed travel, horizontal scanning range and all other PHS operating characteristics are the same for the PHS provided with the Vision series scanners as those of the PHS provided with the ECAT EXACT series scanners. The maximum patient weight specification for the Vision series PHS, is 182 kg (400 lbs). The acquisition computer system is an ACS III system, similar to that used for the ECAT PET/CT system (K002715). Image reconstruction for the ECAT Vision scanners is performed using a dedicated reconstruction computer. The reconstruction algorithm is FOREJ rebinning and 2D Attenuation Normalization Weighted OSEM (ANW-OSEM). The reconstruction system interfaces with the acquisition raid disk system for access to the basic acquired data. The operating console computer is an updated version of the existing ECAT PET/CT operating console. The console runs Siemens Syngo software, with CPS ECAT PET acquisition and application software overlaying the Siemens software. This computer is based on an Intel Pentium system running Microsoft's Windows 2000, or later, operating system. Operating in a syngo-based, NT environment, the ECAT Vision operating software provides acquisition, display, diagnostic, application, system, archival, and retrieval support capabilities. Initially, whole-body oncology applications and visualization tools are being provided.

The CPS/Siemens ECAT LSO PET/CT system is a combined positron emission tomography (PET) and Xray computed tomography (CT) scanner. The ECAT LSO PET/CT scanner is intended to be utilized by appropriately trained health care professionals to 1) image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body; and 2) to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles. The PET and the CT functions of this system can also be used in combination to provide high resolution, noise free CT attenuation correction maps for PET images and, additionally, utilized to produce fused CT and PET images, providing detailed anatomic and metabolic function information in a single image. (*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube and the simultaneous translation of the patient. }

The ECAT LSO PET/CT is a combined position emission tomography (PET) and X-ray computed tomography (CT) scanner. This dual modality tomograph is a modified version of the ECAT PET/CT (K002715) and will utilize the same CT component from the Siemens SOMATOM EMOTION (CT) Scanner. However, in place of the PET component that uses 288 BGO crystal block detectors, the ECAT LSO PET/CT will be configured with the CPS ECAT ACCEL PET (K002584) using 144 LSO crystal block detectors, in combination with the Siemens Somatom EMOTION CT. As with the predicate system, 2D PET acquisition and the PET transmission sources are not included in the modified ECAT LSO PET/CT. PET acquisition data is acquired only in 3D and PET attenuation correction map data is obtained from the CT. The PET and CT components will be integrated as in the original ECAT PET/CT to create an integrated, PET, CT, and combined PET/CT, tomographic imaging system. The ECAT LSO PET/CT gantry structure, patient handling system (PHS), advanced computational system (ACS 3), and workstations will remain essentially the same as the ECAT PET/CT system with only minor modifications to accommodate the different PET detectors. In addition, the ECAT LSO PET/CT as well as the HR+ based ECAT PET/CT will also be offered with either the Siemens single slice EMOTION CT (K991764) or the dual slice EMOTION MS CT (K003074), for the CT component of the system. The EMOTION MS CT with two rows of X-ray detectors does not otherwise affect performance of the ECAT LSO PET/CT.