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The uPMR 790 system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information, acquired simultaneously and iso-centrically. The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and/or PET imaging. The MR is intended to produce sagittal, transverse, coronal, and oblique cross sectional images, and spectroscopic images, and that display internal anatomical structure and/or function of the head, body and extremities. Contrast agents may be used depending on the reqion of interest of the scan. The PET provides distribution information of PET radiopharmaceuticals within the human body to assist healthcare providers in assessing the metabolic and physiological functions. The combined system utilizes the MR for radiation-free attenuation correction maps for PET studies. The system provides inherent anatomical reference for the fused PET and MR images due to precisely aligned MR and PET image coordinate systems.

The uPMR 790 system is a combined Magnetic Resonance Diagnostic Device (MRDD) and Positron Emission Tomography (PET) scanner. It consists of components such as PET detector, 3.0T superconducting magnet, RF power amplifier, RF coils, gradient power amplifier, gradient coils, patient table, spectrometer, computer, equipment cabinets, power distribution system, internal communication system, vital signal module, and software etc. The uPMR 790 system provides simultaneous acquisition of high resolution metabolic and anatomic information from PET and MR. PET detectors are integrated into the MR bore for simultaneous, precisely aligned whole body MR and PET acquisition. The PET subsystem supports Time of Flight (ToF). The system software is used for patient management, data management, scan control, image reconstruction, and image archive. The uPMR 790 system is designed to conform to NEMA and DICOM standards. This traditional 510(k) is to request modifications for the cleared uPMR 790(K222540). The modifications performed on the uPMR 790 (K222540) in this submission are due to the following changes that include: - (1) Addition of RF coils: SuperFlex Body 24, SuperFlex Large -12, SuperFlex Small -12. - (2) Addition and modification of pulse sequences: - (a) New sequences: gre fine, fse arms dwi, fse dwi, fse mars sle, grase, gre_bssfp_ucs, gre_fq, gre_pass, gre_quick_4dncemra, gre_snap, gre_trass, gre_rufis, epi_dwi_msh, svs_wfs, svs_stme. - (b) Added Associated options for certain sequences: QScan, MultiBand, Silicon-Only Imaging, MoCap-Monitoring, T1rho, CEST, Inline T2 mapping, CASS, inline FACT, uCSR, FSP+, whole heart coronary angiography imaging, mPLD (Only output original control/labeling images and PDw(Proton Density weighted) images, no quantification images are output). - (c) Name change of certain sequences: gre ute(old name: gre ute sp), svs_press(old name: press),svs_steam(old name: steam), csi_press(old name: press), csi hise(old name: hise). - (3) Addition of MR imaging processing methods: 2D Flow, 4D Flow, SNAP, CEST, T1rho, FSP+, CASS, PASS, Inline T2 Mapping and DeepRecon. - (4) Addition and modification of PET imaging processing methods: - (a) The new PET imaging processing methods: Hyper DPR (also named HYPER AiR) and Digital Gating (also named Self Gating). - (b) The modified method: HYPER Iterative. - (5) Addition of MR image reconstruction methods: AI-assisted Compressed Sensing (ACS). - (6) Addition and modification of workflow features: - (a) The new workflow features: EasyCrop, MoCap-Monitoring and QGuard-Imaging. - (b) The modified workflow feature: EasyScan. - (7) Addition Spectroscopy: Liver Spectroscopy, Breast Spectroscopy. - (8) Additional function: MR conditional implant mode.

The uPMR 790 system combines magnetic resonance diagnostic devices (MRDD) and Position Tomography (PET) scanners that provide registration of high resolution physiologic and anatomic information, acquired simultaneously and iso-centrically. The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and/or PET imaging. The MR is intended to produce sagittal, transverse, coronal, and oblique cross sectional images, and that display internal anatomical structure and/or function of the head, body and extremities. Contrast agents may be used depending on the region of interest of the scan. The PET provides distribution information of PET radiopharmaceuticals within the human body to assist healthcare providers in assessing the metabolic and physiological functions. The combined system utilizes the MR for radiation-free attenuation correction maps for PET studies. The system provides inherent anatomical reference for the fused PET and MR images due to precisely aligned MR and PET image coordinate systems.

The uPMR 790 system is a combined Magnetic Resonance Diagnostic Device (MRDD) and Positron Emission Tomography (PET) scanner. It consists of components such as PET detector, 3.0T superconducting magnet, RF power amplifier, RF coils, gradient power amplifier, gradient coils, patient table, spectrometer, computer, equipment cabinets, power distribution system, internal communication system, vital signal module, and software etc. The uPMR 790 system provides simultaneous acquisition of high resolution metabolic and anatomic information from PET and MR. PET detectors are integrated into the MR bore for simultaneous, precisely aligned whole body MR and PET acquisition. The PET subsystem supports Time of Flight (ToF). The system software is used for patient management, data management, scan control, image reconstruction, and image archive. The uPMR 790 system is designed to conform to NEMA and DICOM standards.

The SIGNA PET/MR system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information, acquired simultaneously and isocentrically. The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and / or PET imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in the detection, localization, and diagnosis of diseases and disorders. MR is intended to produce transverse, sagittal, coronal and oblique cross-sectional MR images, spectroscopic images and/or spectra, and displays the internal structure and/or function of the human body. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, approved contrast agents may be used, as described in their labeling. This system may also be used for imaging during interventional procedures when performed with MR compatible devices, such as MR safe biopsy needles. PET images and measures the distribution of PET radiopharmaceuticals in humans to aid the physician in determining various metabolic (molecular) and physiologic functions within the human body for evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The combined system utilizes the MR for radiation correction maps for PET studies. The system provides inherent anatomical reference for the fused PET and MR images due to precisely aligned MR and PET image coordinate systems.

The GE SIGNA PET/MR system is a combined Magnetic Resonance Diagnostic Device (MRDD) and Positron Emission Tomography (PET) scanner. The system is designed for whole body oncology, neurology and cardiology examinations. The SIGNA PET/MR system provides simultaneous acquisition of high resolution metabolic and anatomic information from the two major components of each system (MR and PET). Additional components of the system include: a detachable patient table and both the acquisition and processing workstations with associated software. The SIGNA PET/MR includes a 3.0T superconducting magnet, gradient coil and a transmit/receive whole body radiofrequency coil. The system includes patient adaptable RF shimming capabilities. The SIGNA PET detectors are integrated into the MR bore. This allows for simultaneous, precisely aligned whole body MR and PET acquisitions. The PET subsystem supports Time of Flight (ToF) coincidence detection. The SIGNA PET/MR software is used for patient management, data management, scan control, image reconstruction and image archival and evaluation. All images conform to DICOM imaging format requirements. The modifications to this system include the MotionFree Brain software feature, which allows users the flexibility to correct patient head motion using the acquired PET data from the exam, without the need of external tracking devices, additional MR data, or other motion tracking data schemes.

The Siemens MR-PET system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information, acquired simultaneously and isocentrically. The combined sys tem maintains independent functionality of the MR and PET devices, allowing for single modality MR and / or PET imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in the detection, localization, and diagnosis of diseases and disorders. The MR is intended to produce transverse, sagittal, coronal and obligue crosssectional MR images, spectroscopic images and/or spectra, and displays the internal structure and/or function of the human body. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, approved contrast agents may be used, as described in their label ing. This system may also be used for imaging during interventional procedures when performed with MR compatible devices, such as MR safe biopsy needles. The PET images and measures the distribution of PET radiopharmaceuticals in humans to aid the physician in determining various metabolic (molecular) and physiologic functions within the human body for evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The combined system utilizes the MR for radiation-free attenuation correction maps for PET studies. The system provides inherent anatomical reference for the fused PET and MR images due to precisely aligned MR and PET image coordinate systems.

The subject device, syngo MR E11P-AP01 system software for the Biograph mMR system, is a modification of the previously cleared predicate device Biograph mMR with syngo MR E11P system software (K163234, cleared February 28, 2017). The subject device has been modified to include the new mMR 32 Head coil for combined MR-PET usage as well as improvements to the system software syngo MR E11P. - Improvement of the SPACE pulse sequence type with: - CAIPIRINHA acquisition technique named as CAIPIRINHA o SPACE (migrated from previously cleared reference device K173592) - Additional magnetization preparation mode "Non-sel. T2 prep. IR" o for brain imaging with improved dark-fluid contrast. - Implementation of "CP-only" RF transmission mode based on the । requirements of 60601-2-33 Ed. 3.2:2015.

The uPMR 790 system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration of high resolution physiologic and anatomic information, acquired simultaneously and iso-centrically. The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and/or PET imaging. The MR is intended to produce sagittal, transverse, coronal, and oblique cross sectional images, and spectroscopic images, and that display internal anatomical structure and/ or function of the head, body and extremities. Contrast agents may be used depending on the region of interest of the scan. The PET provides distribution information of PET radiopharmaceuticals within the human body to assist healthcare providers in assessing the metabolic and physiological functions. The combined system utilizes the MR for radiation-free attenuation correction maps for PET studies. The system provides inherent anatomical reference for the fused PET and MR images due to precisely aligned MR and PET image coordinate systems.

The uPMR 790 system is a combined Magnetic Resonance Diagnostic Device (MRDD) and Positron Emission Tomography (PET) scanner. It consists of components such as PET detector, 3.0T superconducting magnet. RF power amplifier, RF coils, gradient power amplifier, gradient coils, patient table, spectrometer, computer, equipment cabinets, power distribution system, internal communication system, vital signal module, and software etc. The uPMR 790 system provides simultaneous acquisition of high resolution metabolic and anatomic information from PET and MR. PET detectors are integrated into the MR bore for simultaneous, precisely aligned whole body MR and PET acquisition. The PET subsystem supports Time of Flight (ToF). The system software is used for patient management, data management, scan control, image reconstruction, and image archive. The uPMR 790 system is designed to conform to NEMA and DICOM standards.

The uPMR 790 system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration of high resolution physiologic and anatomic information, acquired simultaneously and iso-centrically. The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and/or PET imaging. The MR is intended to produce sagittal, transverse, coronal, and oblique cross sectional images, and spectroscopic images, and that display internal anatomical structure and/ or function of the head, body and extremities. Contrast agents may be used depending on the region of interest of the scan. The PET provides distribution information of PET radiopharmaceuticals within the human body to assist healtheare providers in assessing the metabolic and physiological functions. The combined system utilizes the MR for radiation-free attenuation correction maps for PET studies. The system provides inherent anatomical reference for the fused PET and MR images due to precisely aligned MR and PET image coordinate systems.

The uPMR 790 system is a combined Magnetic Resonance Diagnostic Device (MRDD) and Positron Emission Tomography (PET) scanner. It consists of components such as PET detector, 3.0T superconducting magnet, RF power amplifier, RF coils, gradient power amplifier, gradient coils, patient table, spectrometer, computer, equipment cabinets, power distribution system, internal communication system, vital signal module, and software etc. The uPMR 790 system provides simultaneous acquisition of high resolution metabolic and anatomic information from PET and MR. PET detectors are integrated into the MR bore for simultaneous, precisely aligned whole body MR and PET acquisition. The PET subsystem supports Time of Flight (ToF). The system software is used for patient management, data management, scan control, image reconstruction, and image archive. The uPMR 790 system is designed to conform to NEMA and DICOM standards.

The Siemens MR-PET system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information, acquired simultaneously and isocentrically. The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and / or PET imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in the detection, localization, and diagnosis of diseases and disorders. The MR is intended to produce transverse, sagittal, coronal and oblique crosssectional MR images, spectroscopic images and/or spectra, and displays the internal structure and/or function of the human body. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, approved contrast agents may be used, as described in their labeling. This system may also be used for imaging during interventional procedures wen performed with MR compatible devices, such as MR safe biopsy needles. The PET images and measures the distribution of PET radiopharmaceuticals in humans to aid the physician in determining various metabolic (molecular) and physiologic functions within the human body for evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The combined system utilizes the MR for radiation correction maps for PET studies. The system provides inherent anatomical reference for the fissed PET and MR images due to precisely aligned MR and PET image coordinate systems.

The new mMR Angio Transfer Option is being introduced for the Biograph mMR system. The new option is intended to provide a patient transfer from the SIEMENS Artis Q and Artis Q.zen (K123529) or Artis zee/zeego SW VC21 (K141574) System to the Biograph mMR and vice versa. To achieve this functionality a Transferboard Artis (further named as Transferboard) will be used where the patient is located and transferred. This Transferboard can be adapted on the standard table of the Artis Q and Artis Q.zen (K123529) or Artis zee/zeego SW VC21 (K141574) System. The standard table is identical for all models. By swiveling the Artis Q. Artis Q.zen or Artis zee /zeego table (standard function) the Transferboard will be positioned in front of the Biograph mMR. Via the Guiding Slide Way the Transferboard is pushed manually on the Table Top of the Biograph mMR. The Guiding Slide Way is also included in the option and is installed on the Table Top of the Biograph mMR instead of a regular patient cushion. The Transferboard is also used to move the patient into the bore of the Biograph mMR for further diagnostic imaging. The basic device and its functionality remain unchanged except for the following modifications: - . Coil Adapter Cover (CAC): The Coil Adapter Cover will replace the standard mMR coil adapter cover on the foot end of the mMR tabletop to enable the overtraveling of the Transferboard (TFB). - Guiding Slide Wav (GSW): A Guiding Slide Way (GSW) will be adapted on the ● existing Biograph mMR tabletop. This is a foldable option and can be removed for diagnostic mMR examination in case the transfer option is not needed. - Transferboard (TFB): The Transferboard (TFB) is intended to transfer the ● patient. The patient remains on this board during the whole intraoperative procedure. - Patient Cushion (LGH): The Patient Cushion is laid on the Transferboard (TFB) for comfortable reclining. - Fixation Belts: The Fixation Belts are used for preventing the patient to fall of ● the Transferboard and Patient Cushion during transport, surgery and imaging, - Transfer Support Cart (TSC): The Transfer Support Cart is part of the option. ● It ensures that both tables have the same height and that there are no vibrations during transfer due to load changes on the patient tables The new mMR Angio Transfer Option for the Biograph mMR system requires the most recent Device Software, syngo MR E11P software cleared via 510(k) on February 28, 2017 (K163234).

The Siemens MR-PET system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. acquired simultaneously and isocentrically. The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and / or PET imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in the detection, localization, and diagnosis of diseases and disorders. The MR is intended to produce transverse, sagittal, coronal and oblique crossectional MR images, spectroscopic inages and/or spectra, and displays the internal structure and/or function of the human body. Other physical parameters derived from the images and or spectra may also be produced. Depending on the region of interest, approved contrast agents may be used, as described in their labeling. This system may also be used for imaging during interventional procedures when performed with MR compatible devices, such as MR safe biopsy needles. The PET images and measures the distribution of PET radiopharmaceuticals in humans to aid the physician in determining various metabolic (molecular) and physiologic functions within the human body for evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The combined system utilizes the MR for radiation-free attenuation correction maps for PET studies. The system provides inherent anatomical reference for the fised PET and MR images due to precisely aligned MR and PET image coordinate systems.

The subject device, syngo MR E11P system software, is being introduced for the Biograph mMR system. The syngo MR E11P SW includes new sequences, new features and minor modifications of already existing features. A high level summary of the new sequences and features is included below. Migrated sequences and features from the previously cleared secondary predicate devices MAGNETOM Verio with syngo MR D13A and Siemens E-line Software with MAGNETOM Skyra with syngo MR E11C (K153343) are not described separately as these are commercially available and no changes are introduced for this system. Improvement in Attenuation Correction Atlas-based bones in u-map generation The bone attenuation map is computed based on a reqular 4-compartment (air, lung, fat, water) segmentation from a Dixon sequence. As improvement, the bone information is added to these u-maps with a model-based bone segmentation algorithm using continuous linear attenuation coefficients (LACs) for bone to represent the variation in cortical bone density in different anatomical areas. The model consists of the most relevant bones in the body torso in terms of overall attenuation. It consists of the skull, spine, pelvis and femur bone as individual components. MR based FoV extension for attenuation correction - (HUGE) In this SW version syngo MR E11P the attenuation map can be improved by using an optional MR-based FoV extension technique. This technique requires an additional MR measurement optimized for distortion reduced acquisition of the patient's arms resting along the body at the edge of the FoV. New and Modified Features Multimodal (Elastic) Motion Correction (BodyCOMPASS) Elastic motion correction is introduced to reduce the effect of blur induced by respiratory motion during a PET acquisition. As a basic principle, periodic motion information is collected by means of the MR as a 4D image series and used for PET to - . bin the PET counts into separate respiratory states - provide a mapping for each spatial position and each respiratory state to a . reference state, which can be used in the PET reconstruction Hence, the resulting PET image combines the advantages of a gated PET image with reduced motion blur while preserving the signal-to-noise ratio of static non-gated reconstruction. Improvement in DIXON fat water separation In this SW version syngo MR E11P the DIXON reconstruction technique (fat/water separation) is improved. The improved algorithm is based on global optimization and thus minimizes the probability of local fat/water swaps where part of water image is wrongly assigned to fat image and/or vice versa. Dot Cockpit (DotGO), including PET Workflow The previously cleared DotGO with the Dot Cockpit and the MR only Dot Engines is now available on the Biograph mMR with syngo MR E11P. The configuration of PET workflows is now integrated into the Dot Cockpit for higher productivity. This modification increases the robustness and usability for the clinical workflow with the new PET Planning Group. PET Planning Step and special reduced MR Parameter cards while still offering the full parameter access with detail views, PET and AC specific steps with their parameter cards. Improved MR PET Workflow With the software syngo MR E11P a set of protocols are included in order to run a clinical whole body workflow with 5 beds, AC, T1-, T2-, DWI-contrast, adjustments and SAR pauses in 45 minutes. In this workflow the AC protocol is acquired in high resolution (1.3 mm * 1.3mm in plane) using CAIPIRINHA acceleration. Alternatively, an AC protocol in conventional resolution (2.6 mm * 2.6 mm in plane) using CAIPIRINHA acceleration is available in order to reduce the acquisition time for AC measurement in case T1-contrast is not requested from AC scan. Other Software Improvements NEMA NU 2:2012 As it is possible that routine NEMA testing may be required to retain ACR accreditation, Siemens has developed an optional software package which enables a Biograph mMR system user to quantify image quality for certain performances according to the most recent available NEMA standards. Improvements in Retro Recon Task Card In the RetroRecon Task Card of the Biograph mMR with syngo MR E11P, an additional identifier in the list of the parameter Attenuation Correction indicates gated u-Maps. Furthermore a Tooltip for the Attenuation Correction parameter explains the identifier. For respiratory gating a new Respiratory Curve Display shows the recorded cushion signal as well as the specified gates for some gating types. Third Party Interface for AC An Interface functionality is added to the synqo MR E11P software to import attenuation maps of third party components for hardware attenuation correction. Other Modifications Front Cover Panel Refresh for Biograph mMR The Biograph mMR with syngo MR E11P will receive new system covers. The graphic design of the cover has been changed to give the systems an updated and more modern look to highlight the introduction of a new software version. MaRS - technology for Biograph mMR The modified control system of the Biograph mMR integrates the functions of the AMC (Advanced Measurement Control) and MRIR (MR Image Reconstructor) into one computer called MaRS (Measurement and Reconstruction System). The MaRS system performs sequence control and image reconstruction without additional MRIR. The introduction of the MaRS was part of the secondary predicate device MAGNETOM Verio with syngo MR D13A (K121434). This is now updated to new computer hardware with this submission. Physiological Monitoring Unit (PMU) The Physiological Measurement Unit (PMU) was modified to improve the accuracy of triggers on the respiration signal. The PMU provides ECG, respiration and peripheral pulse as well as external trigger input to control of the MR imaging sequences for synchronization. Syngo MR Software Features Other features were included unchanged from the secondary predicate devices (K121434 and K153343). These features expand the Biograph mMR's MR scanning capabilities and update the feature set to be more similar to currently released Siemens MR software.

The SIGNA PET/MR system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information, acquired simultaneously and isocentrically. The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and / or PET imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in the detection, localization, and diagnosis of diseases and disorders. MR is intended to produce transverse, sagittal, coronal and oblique cross-sectional MR images, spectroscopic images and/ or spectra, and displays the internal structure and/or function of the human body. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, approved contrast agents may be used, as described in their labeling. This system may also be used for imaging during interventional procedures when performed with MR compatible devices, such as MR safe biopsy needles. PET images and measures the distribution of PET radiopharmaceuticals in humans to aid the physician in determining various metabolic (molecular) and physiologic functions within the human body for evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The combined system utilizes the MR for radiation-free attenuation correction maps for PET studies. The system provides inherent anatomical reference for the fused PET and MR images due to precisely aligned MR and PET image coordinate systems.

The GE SIGNA PET/MR system is a combined Magnetic Resonance Diagnostic Device (MRDD) and Positron Emission Tomography (PET) scanner. The system is designed for whole body oncology, neurology and cardiology examinations. The SIGNA PET/MR system provides simultaneous acquisition of high-resolution metabolic and anatomic information from the two major components of each system (MR and PET). Additional components of the system include: a patient table and both the acquisition and processing workstations with associated software. The SIGNA PET/MR includes a 3.0T superconducting magnet, gradient coil and body coil. The system includes dual drive capabilities. The SIGNA PET detectors are integrated into the MR bore. This allows for simultaneous, precisely aligned whole body MR and PET acquisition. The PET subsystem supports Time of Flight (ToF). The SIGNA PET/MR software is used for patient management, data management, scan control, image reconstruction and image archival and evaluation. All images conform to DICOM imaging format requirements.

The SIGNA PET/MR system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information, acquired simultaneously and isocentrically. The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and / or PET imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in the detection, and diagnosis of diseases and disorders. MR is intended to produce transverse, sagittal, coronal and oblique cross-sectional MR images and/ or spectra, and displays the internal struction of the human body. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, approved contrast agents may be used, as described in their labeling. This system may also be used for imaging during interventional procedures when performed with MR compatible devices, such as MR safe biopsy needles. PET images and measures the distribution of PET radiopharmaceuticals in humans to aid the physician in determining various metabolic (molecular) and physiologic functions within the human body for evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The combined system utilizes the MR for radiation correction maps for PET studies. The system provides inherent anatomical reference for the fused PET and MR images due to precisely aligned MR and PET image coordinate systems.

The GE SIGNA PET/MR system is a combined Magnetic Resonance Diagnostic Device (MRDD) and Positron Emission Tomography (PET) scanner. The system is designed for whole body oncology, neurology and cardiology examinations. The SIGNA PET/MR system provides simultaneous acquisition of high-resolution metabolic and anatomic information from the two major components of each system (MR and PET). Additional components of the system include: a patient table and both the acquisition and processing workstations with associated software. The SIGNA PET/MR includes a 3.0T superconducting magnet, gradient coil, body coil and local surface RF coils based on those of the reference device Discovery MR750w 3.0T. The system includes dual drive capabilities. The SIGNA PET detectors have been modified from those of the reference device, the Discovery PET/CT 690, to allow them to be integrated into the bore of the MR. This allows for simultaneous, precisely aligned whole body MR and PET acquisition. Similar to Discovery PET/CT D690, PET supports Time of Flight (ToF). SIGNA PET/MR software is based on a combination of Discovery MR750w with Discovery PET/CT 690 software. It is used for patient management, data management, scan control, image reconstruction and image archival and evaluation. All images conform to DICOM imaging format requirements. The SIGNA PET/MR system and surface coil suite, the subject of this application, is substantially equivalent to the commercially available devices above with modifications made to integrate the two modalities together into a whole-body system.