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The MAGNETOM system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross-sectional images, spectroscopic images and/or spectra, and that displays, depending on optional local coils that have been configured with the system, the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis. The MAGNETOM system may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room displays and MR Safe biopsy needles.

MAGNETOM Flow.Ace and MAGNETOM Flow.Plus are 60cm-bore MRI systems with quench pipe-free, sealed magnets utilizing DryCool technology. They are equipped with BioMatrix technology and run on Siemens' syngo MR XA70A software platform. The systems include Eco Power Mode for reduced energy and helium consumption. They have different gradient configurations suitable for all body regions, with stronger configurations supporting advanced cardiac imaging. Compared to the predicate device, new hardware includes a new magnet, gradient coil, RF system, local coils, patient tables, and computer systems. New software features include AutoMate Cardiac, Quick Protocols, BLADE with SMS acceleration for non-diffusion imaging, Deep Resolve Swift Brain, Fast GRE Reference Scan, Ghost reduction, Fleet Reference Scan, SMS Averaging, Select&GO extension, myExam Spine Autopilot, and New Startup-Timer. Modified features include improvements for Pulse Sequence Type SPACE, improved Gradient ECO Mode Settings, and Inline Image Filter switchable for users.

The MAGNETOM system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis. The MAGNETOM system may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room displays and MR Safe biopsy needles.

The subject device, MAGNETOM Avanto Fit with software syngo MR XA70A, consists of new and modified software and hardware that is similar to what is currently offered on the predicate device, MAGNETOM Avanto Fit with syngo MR XA50A (K220151). A high-level summary of the new and modified hardware and software is provided below: For MAGNETOM Avanto Fit with syngo MR XA70: Hardware New Hardware: myExam 3D Camera BM Head/Neck 20 Modified Hardware: Sanaflex (cushions for patient positioning) Software New Features and Applications: myExam Autopilot Brain myExam Autopilot Knee 3D Whole Heart HASTE_interactive GRE_PC Open Recon Deep Resolve Gain Fleet Reference Scan Physio logging complex averaging AutoMate Cardiac Ghost Reduction BLADE diffusion Beat Sensor Deep Resolve Sharp Deep Resolve Boost and Deep Resolve Boost (TSE) Deep Resolve Boost HASTE Deep Resolve Boost EPI Diffusion Modified Features and Applications: SPACE improvement (high band) SPACE improvement (incr grad) Brain Assist Eco power mode myExam Angio Advanced Assist (Test Bolus) The subject device, MAGNETOM Skyra Fit with software syngo MR XA70A, consists of new and modified software and hardware that is similar to what is currently offered on the predicate device, MAGNETOM Skyra Fit with syngo MR XA50A (K220589). A high-level summary of the new and modified hardware and software is provided below: For MAGNETOM Skyra Fit with syngo MR XA70: Hardware New Hardware: myExam 3D Camera Modified Hardware: Sanaflex (cushions for patient positioning) Software New Features and Applications: Beat Sensor HASTE_interactive GRE_PC 3D Whole Heart Deep Resolve Gain Open Recon Ghost Reduction Fleet Reference Scan BLADE diffusion HASTE diffusion Physio logging complex averaging Deep Resolve Swift Brain Deep Resolve Sharp Deep Resolve Boost and Deep Resolve Boost (TSE) Deep Resolve Boost HASTE Deep Resolve Boost EPI Diffusion AutoMate Cardiac SVS_EDIT Modified Features and Applications: SPACE improvement (high band) SPACE improvement (incr grad) Brain Assist Eco power mode myExam Angio Advanced Assist (Test Bolus) The subject device, MAGNETOM Sola Fit with software syngo MR XA70A, consists of new and modified software and hardware that is similar to what is currently offered on the predicate device, MAGNETOM Sola Fit with syngo MR XA51A (K221733). A high-level summary of the new and modified hardware and software is provided below: For MAGNETOM Sola Fit with syngo MR XA70: Hardware New Hardware: myExam 3D Camera Modified Hardware: Sanaflex (cushions for patient positioning) Software New Features and Applications: GRE_PC 3D Whole Heart Ghost Reduction Fleet Reference Scan BLADE diffusion Physio logging Open Recon Complex averaging Deep Resolve Sharp Deep Resolve Boost and Deep Resolve Boost (TSE) Deep Resolve Boost HASTE Deep Resolve Boost EPI Diffusion AutoMate Cardiac Implant suite Modified Features and Applications: SPACE improvement (high band) SPACE improvement (incr grad) Brain Assist Eco power mode The subject device, MAGNETOM Viato.Mobile with software syngo MR XA70A, consists of new and modified software and hardware that is similar to what is currently offered on the predicate device, MAGNETOM Viato.Mobile with syngo MR XA51A (K240608). A high-level summary of the new and modified hardware and software is provided below: For MAGNETOM Viato.Mobile with syngo MR XA70: Hardware New Hardware: n.a. Modified Hardware: Sanaflex (cushions for patient positioning) Software New Features and Applications: GRE_PC 3D Whole Heart Ghost Reduction Fleet Reference Scan BLADE diffusion Physio logging Open Recon Complex averaging Deep Resolve Sharp Deep Resolve Boost and Deep Resolve Boost (TSE) Deep Resolve Boost HASTE Deep Resolve Boost EPI Diffusion AutoMate Cardiac Implant suite Modified Features and Applications: SPACE improvement (high band) SPACE improvement (incr grad) Brain Assist Eco power mode Furthermore, the following minor updates and changes were conducted for the subject devices: Low SAR Protocol minor update (for all subject devices but MAGNETOM Skyra Fit): the goal of the SAR adaptive protocols was to be able to perform knee, spine, heart and brain examinations with 50% of the max allowed SAR values in normal mode for head and whole-body SAR. The SAR reduction was achieved by parameter adaptations like Flip angle, TR, RF Pulse Type, Turbo Factor, concatenations. For cardiac clinically accepted alternative imaging contrasts are used (submitted with K232494). Implementation of image sorting prepare for PACS (submitted with K231560). Implementation of improved DICOM color support (submitted with K232494). Needle intervention AddIn was added all subject device (submitted with K232494). Inline Image Filter switchable for users: in the subject device, users have the ability to switch the "Inline image filter" (implicite Filter) on or off. This filter is an image-based filter that can be applied to specific pulse sequence types. The function of the filter remains unchanged from the previous device MAGNETOM Sola with syngo MR XA61A (K232535). SVS_EDIT is newly added for MAGNETOM Skyra Fit, but without any changes (submitted with K203443) Brain Assist received an improvement and is identical to that of snygo MR XA61A (K232535) Open Recon is introduced for all systems. The function of Open Recon remains unchanged from the previous submissions (submitted with K221733). Lock TR and FA in Bold received a minor UI update Implant Suite is newly introduced for MAGNETOM Sola Fit and MAGNETOM Viato.Mobile, but without any changes (submitted with K232535) myExam Autopilot Brain and myExam Autopilot Knee are newly introduced for the subject device MAGNETOM AVANTO Fit and are unchanged from previous submissions (submitted with K221733). myExam Angio Advanced Assist (Test Bolus) received a bug fixing and minimal UI improvements.

Sonic DL is a Deep Learning based reconstruction technique that is available for use on GE HealthCare 1.5T, 3.0T, and 7.0T MR systems. Sonic DL reconstructs MR images from highly under-sampled data, and thereby enables highly accelerated acquisitions. Sonic DL is intended for imaging patients of all ages. Sonic DL is not limited by anatomy and can be used for 2D cardiac cine imaging and 3D Cartesian imaging using fast spin echo and gradient echo sequences. Depending on the region of interest, contrast agents may be used.

Sonic DL is a software feature intended for use with GE HealthCare MR systems. It includes a deep learning based reconstruction algorithm that enables highly accelerated acquisitions by reconstructing MR images from highly under-sampled data. Sonic DL is an optional feature that is integrated into the MR system software and activated through purchasable software option keys.

Philips Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. This MR system enables trained physicians to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation, representing the spatial distribution of protons or other nuclei with spin. Image appearance is determined by many different physical properties of the tissue and the anatomy, the MR scan technique applied, and presence of contrast agents. The use of contrast agents for diagnostic imaging applications should be performed consistent with the approved labeling for the contrast agent. The trained clinical user can adjust the MR scan parameters to customize image appearance, accelerate image acquisition, and synchronize with the patient's breathing or cardiac cycle. The systems can use combinations of images to produce physical parameters, and related derived images. Images, spectra, and measurements of physical parameters, when interpreted by a trained physician, provide information that may assist diagnosis and therapy planning. The accuracy of determined physical parameters depends on system and scan parameters and must be controlled and validated by the clinical user. In addition, the Philips MR systems provide imaging capabilities, such as MR fluoroscopy, to guide and evaluate interventional and minimally invasive procedures in the head, body and extremities. MR Interventional procedures, performed inside or adjacent to the Philips MR system, must be performed with MR Conditional or MR Safe instrumentation as selected and evaluated by the clinical user for use with the specific MR system configuration in the hospital. The appropriateness and use of information from a Philips MR system for a specific interventional procedure and specific MR system configuration must be validated by the clinical user.

The subject Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR Systems are 60 cm and 70 cm bore 1.5 and 3.0 Tesla (1.5T and 3.0T) Magnetic Resonance Diagnostic Devices. A new optional software feature SmartSpeed Precise is contained in software R12.3 for the subject Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR Systems. SmartSpeed Precise is a machine learning based reconstruction technique designed to increase the signal-to-noise (SNR), increase the sharpness, and reduce residual ringing artifacts in MR images. The introduction of SmartSpeed Precise only required updates to the MR System Software. The subject Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR Systems are intended to be marketed with the same pulse sequences and coils that are previously cleared by FDA: The accessories to be used with the subject Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR Systems have not changed compared to the predicate device and can be found in the Instructions for Use accompanying the device. When Philips MRI system is used in combination with the Philips MR-RT or MR-OR solutions, the user is referred to the dedicated MR-RT and MR-OR Instructions for Use for information on additional accessories that may apply.

Indications for use vary depending on the specific product and its intended application. These products are designed for use in medical or laboratory settings by trained professionals. Depending on the device, intended uses may include: * **Diagnostic purposes:** Analyzing biological samples (e.g., blood, urine, tissue) to identify diseases, conditions, or other health markers. This can include detecting infections, monitoring chronic illnesses, or screening for genetic predispositions. * **Therapeutic procedures:** Assisting in or performing medical interventions, such as administering medications, delivering fluids, or providing respiratory support. * **Research and development:** Used in laboratory experiments and studies to investigate biological processes, test new drugs, or develop new medical technologies. * **Monitoring physiological parameters:** Measuring heart rate, blood pressure, oxygen saturation, or other vital signs. * **Sample collection and preparation:** Gathering, processing, and storing biological samples for further analysis. Specific indications for use are provided in the product's labeling, instructions for use (IFU), or accompanying documentation. Users should always refer to the manufacturer's provided information for the most accurate and complete indications.

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The uMR Omega system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces 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. These images and the physical parameters derived from the images when interpreted by a trained physician yield information that may assist the diagnosis. Contrast agents may be used depending on the region of interest of the scan.

The uMR Omega is a 3.0T superconducting magnetic resonance diagnostic device with a 75cm size patient bore. It consists of components such as magnet, RF power amplifier, RF coils, gradient power amplifier, gradient coils, patient table, spectrometer, computer, equipment cabinets, power distribution system, internal communication system, and vital signal module etc. The uMR Omega Magnetic Resonance Diagnostic Device is designed to conform to NEMA and DICOM standards. This traditional 510(k) is to request modifications for the cleared uMR Omega(K240540). The modifications performed on the uMR Omega in this submission are due to the following changes that include: 1. **Addition of RF coils and corresponding accessories:** Breast Coil - 12, Biopsy Configuration, Head Coil - 16, Positioning Couch-top, Coil Support, Tx/Rx Head Coil. 2. **Modification of the mmw component name:** from mmw100 to mmw101. 3. **Modification of the dimensions of detachable table:** from width 826mm, height 880mm, length 2578mm to width 810mm, height 880mm, length 2505mm. 4. **Addition and modification of pulse sequences:** - a) New sequences: gre_pass, gre_mtp, epi_dti_msh, gre_fsp_c(3D LGE). - b) Added Associated options for certain sequences: fse(MicroView), fse_mx(MicroView), gre(Output phase image), gre_swi(QSM), gre_fsp_c(DB/GB PSIR), gre_bssfp(TI Scout), gre_bssfp_ucs(Real Time Cine), epi_dwi(IVIM), epi_dti(DSI, DKI). - c) Added Additional accessory equipment required for certain sequences: gre_bssfp (Virtual ECG Trigger). - d) Added applicable body parts: epi_dwi_msh, gre_fine, fse_mx. 5. **Addition of imaging processing methods:** Inline Cardiac function, Inline ECV, Inline MRS, Inline MOCO and MTP. 6. **Addition of workflow features:** EasyFACT, TI Scout, EasyCrop, ImageGuard, MoCap and Breast Biopsy. 7. **Addition of image reconstruction methods:** SparkCo. 8. **Modification of function:** uVision (add Body Part Recognization), EasyScan(add applicable body parts). The modification does not affect the intended use or alter the fundamental scientific technology of the device.

The Swoop Portable MR Imaging System is a portable, ultra-low field magnetic resonance imaging device for producing images that display the internal structure of the head where full diagnostic examination is not clinically practical. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.

The Swoop system is portable, ultra-low field MRI device that enables visualization of the internal structures of the head using standard magnetic resonance imaging contrasts. The main interface is a commercial off-the-shelf device that is used for operating the system, providing access to patient data, exam setup, exam execution, viewing MRI image data for quality control purposes, and cloud storage interactions. The system can generate MRI data sets with a broad range of contrasts. The Swoop system user interface includes touch screen menus, controls, indicators, and navigation icons that allow the operator to control the system and to view imagery. The Swoop System image reconstruction algorithm utilizes deep learning to provide improved image quality for T1W, T2W, FLAIR, and DWI sequences. The subject Swoop System described in this submission includes software modifications related to the pulse sequences and image processing.

The SIGNA Prime Elite is a whole body magnetic resonance scanner designed to support high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced by SIGNA Prime Elite reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

SIGNA Prime Elite is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan time. The system uses a combination of time-varying magnet fields (Gradients) and RF transmissions to obtain information regarding the density and position of elements exhibiting magnetic resonance. The system can image in the sagittal, coronal, axial, oblique, and double oblique planes, using various pulse sequences, imaging techniques and reconstruction algorithms. The system features a 1.5T superconducting magnet with 60 cm bore size. The system is designed to conform to NEMA DICOM standards (Digital Imaging and Communications in Medicine).

The 16CH Flex SPEEDER Medium is intended for use with Canon 1.5T MR systems to produce diagnostic images of general human anatomy that can be interpreted by a trained physician. The 16ch Flex SPEEDER Large coil is intended for use with Canon 1.5T MR systems to produce diagnostic images of general human anatomy that can be interpreted by a trained physician.

The 16ch Flex Speeder Medium and 16ch Flex Speeder Large coils are a receive-only, 16-channel phased array coil designed for magnetic resonance imaging (MRI) using the Canon 1.5T MR systems. The 16ch Flex Speeder Medium and 16ch Flex Speeder Large coils are intended to be used for general anatomies.

The SureWave Elastography device is intended for use with Siemens 1.5T and 3.0T MRI systems to generate shear wave vibrations in the body of adult patients during an MRI exam that are translated into images representing tissue stiffness. The images may be used for diagnostic purposes when interpreted by a trained physician.

The SureWave Elastography device is an accessory to the MRI system comprised of both hardware and software components. The hardware induces shear wave vibrations in the body through a transducer which is driven by a mobile tower and two flexible rotating axes. The transducer is fastened to the patient's body and contains a rotatable eccentric mass which induces vibrations in the body during an MRI scan. The SureWave Elastography reconstruction software uses the acquired image data from the MRI system to create images that show tissue stiffness.