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The multifunctional ultrasound scanner is used to collect, display and analyze ultrasound images during ultrasound imaging procedures in combination with supported echographic probes. Main application: - Cardiac Districts: Cardiac Adult, Cardiac Pediatric Invasive access: Transesophageal - Vascular Districts: Neonatal, Adult Cephalic, Vascular Invasive access: Not applicable - General Imaging Districts: Abdominal, Breast, Musculoskeletal, Neonatal, Pediatric, Small Organs (Testicles), Thyroid, Urological Invasive access: Intraoperative (Abdominal), Laparoscopic, Transrectal - Women Health Districts: OB/Fetal, Gynecology Invasive access: Transrectal, Transvaginal The primary modes of operation are: B-Mode, M-Mode, Tissue Enhancement Imaging (TEI), Multi View (MView), Doppler (both Pulsed Wave (PW) and Continuous Wave (CW)), Color Flow Mapping (CFM), Power Doppler, Tissue Velocity Mapping (TVM), Combined modes, Elastosonography, 3D/4D and CnTI. The ultrasound scanner is suitable to be installed in professional healthcare facility environment and is designed for ultrasound practitioners.

6600 Ultrasound System is a general-purpose diagnostic ultrasound system, based on a mainframe platform that can be easily moved thanks to four swivelling wheels. 6600 Ultrasound System consists of a control panel assembly with LCD monitor and a console with the device electronics and connectors, housed in an ergonomic cart designed to be both highly mobile and adjustable for a range of users and operating conditions. 6600 Ultrasound System use the physical properties of the ultrasound (i.e. sound waves with frequency above 20 kHz and that are not audible to the human ear) for the visualization of deep structures of the body by recording the reflections or echoes of ultrasonic pulses directed into the tissues and of the Doppler effect, i.e. the frequency-shifted ultrasound reflections produced by moving targets (usually red blood cells) in the bloodstream, to determine both direction and velocity of blood flow in the target organs. The primary modes of operation are: B-Mode, M-Mode, Tissue Enhancement Imaging (TEI), Multi View (MView), Doppler (both PW and CW), Color Flow Mapping (CFM), Power Doppler, Tissue Velocity Mapping (TVM), Combined modes. 6600 Ultrasound System also manages Elastosonography, 3D/4D and CnTI. Several types of probes are used to cover different needs in terms of geometrical shape and frequency range. 6600 Ultrasound System can drive Phased Array, Convex Array, Linear Array, Doppler probes and Volumetric probes (Bi-Scan probes). The control panel is equipped with a pull out Qwerty alphanumeric keyboard that allows data entry. The touchscreen has an emulation of the Qwerty keyboard that allows data entry and has additional controls and mode-depending keys, integrated in the touchscreen. 6600 Ultrasound System is equipped with wireless capability. 6600 Ultrasound System will be available on the market in two models with the following commercial names: MyLabA50, MyLabA70. The difference between MyLabA50 and MyLabA70 models is only in the licenses configuration. 6600 Ultrasound System, defined herein, introduces new features and accessories listed below: 1. AutoOB: AutoOB (Automatic Obstetric Biometric Measurement) is a tool based on A.I. algorithms that supports the clinician in performing the Obstetric Biometric Measurements during an Obstetric ultrasound examination. 2. AutoCM: AutoCM (Automatic Cardiac Measurement), is a tool based on A.I. algorithm that supports the clinician in performing the Cardiac Measurements during a Cardiac ultrasound examination. 3. XStrain RV: XStrain allows clinicians to quantify endocardial velocities of contraction and relaxation and local deformation of the heart (Strain/Strain rate). XStrain RV is an advanced processing package for the Right Ventricle analysis. 4. New probes: C 1-8E, L 3-15E and P 1-5E, available for MyLabA50 model. 5. New probes: C 1-8A and P 1-5A available for MyLabA70 model. 6600 Ultrasound System employs the same fundamental technological characteristics as its predicate device cleared via K230179.

The multifunctional ultrasound scanner is used to collect, display and analyze ultrasound images during ultrasound imaging procedures in combination with supported echographic probes. Main application: Cardiac, Vascular, General Imaging, Women Health. Districts: Cardiac Adult, Cardiac Pediatric, Neonatal, Adult Cephalic, Vascular, Abdominal, Breast, Musculoskeletal, Neonatal, Pediatric, Small Organs (Testicles), Thyroid, Urological, OB/Fetal, Gynecology. Invasive access: Transesophageal, Not applicable, Intraoperative (Abdominal), Laparoscopic, Transrectal, Transvaginal. Virtual Navigator option supports a radiological clinical ultrasound examination (first modality) by providing additional image information from a second imaging modality. As second imaging modality it is intended any image coming from CT, MR, US, PET, XA and NM. The second modality provides additional security in assessing the morphology of the real time ultrasound image. The primary modes of operation are: B-Mode, M-Mode, Tissue Enhancement Imaging (TEI), Multi View (MView), Doppler (both Pulsed Wave (PW) and Continuous Wave (CW)), Color Flow Mapping (CFM), Power Doppler, Tissue Velocity Mapping (TVM), Combined modes, Elastosonography, 3D/4D and CnTI. The ultrasound scanner is suitable to be installed in professional healthcare facility environment and is designed for ultrasound practitioners.

6450 Ultrasound System is a general-purpose diagnostic ultrasound system, based on a mainframe platform that can be easily moved thanks to four swivelling wheels. 6450 Ultrasound System consists of a control panel assembly with LCD monitor and a console with the device electronics and connectors, housed in an ergonomic cart designed to be both highly mobile and adjustable for a range of users and operating conditions. 6450 Ultrasound System use the physical properties of the ultrasound (i.e. sound waves with frequency above 20 kHz and that are not audible to the human ear) for the visualization of deep structures of the body by recording the reflections or echoes of ultrasonic pulses directed into the tissues and of the Doppler effect, i.e. the frequency-shifted ultrasound reflections produced by moving targets (usually red blood cells) in the bloodstream, to determine both direction and velocity of blood flow in the target organs. The primary modes of operation are: B-Mode, M-Mode, Tissue Enhancement Imaging (TEI), Multi View (MView), Doppler (both PW and CW), Color Flow Mapping (CFM), Power Doppler, Tissue Velocity Mapping (TVM), Combined modes. 6450 Ultrasound System also manages Elastosonography (ElaXto, QElaXto, QElaXto 2D), 3D/4D and CnTI. Several types of probes are used to cover different needs in terms of geometrical shape and frequency range. 6450 Ultrasound System can drive Phased Array, Convex Array, Linear Array, Doppler probes and Volumetric probes (Bi-Scan probes). The control panel is equipped with a pull-out Qwerty alphanumeric keyboard that allows data entry. The touchscreen has an emulation of the Qwerty keyboard that allows data entry and has additional controls and mode-depending keys, integrated in the touchscreen. 6450 Ultrasound System is equipped with wireless capability. 6450 Ultrasound System will be available on the market in two models with the following commercial names: MyLabE80, MyLabE85. The difference between MyLabE80 and MyLabE85 models is only in the licenses configuration. For both models, there is the ETC (Easy To Clean) version, having a keyboard with special controls and material, compatible with disinfection procedures. 6450 Ultrasound System, defined herein, introduces new features and accessories listed below: 1. XStrain LA: XStrain allows clinicians to quantify endocardial velocities of contraction and relaxation and local deformation of the heart (Strain/Strain rate). XStrain LA is an advanced processing package for the Left Atrium analysis. 2. New probe: IHX 6-25 6450 Ultrasound System employs the same fundamental technological characteristics as its predicate device cleared via K192157.

The general-purpose magnetic resonance imaging (MRI) device is designed to scan any targeted area of the body, to collect, display and analyze MR images and other real-time imaging procedures. Imaging portions of calf, knee, ankle, foot, thigh, hand, wrist, forearm, elbow, arm, shoulder, hip, lumbar column, sacral column, cervical column, thoracic spine, pelvis, temporomandibular joint (included only for "Open" configuration), head (included only for "Open" configuration). MRI provides better soft tissue contrast than CT and can differentiate better between fat, water, muscle, and other soft tissue than CT (CT is usually better at images provide information to physicians and can be useful in diagnosing a wide variety of diseases and conditions.

The new Magnifico EVO 23 employs the same fundamental scientific technology as its predicate device, the first version of Esaote Magnifico, cleared via K212419. The modifications, do not affect the intended use or alter the fundamental scientific technology of the device. The software, used on the proposed Magnifico system has been modified, from EVO 21 to include the • LSDWI sequence for brain examination - · MR Angiography · Maximum Intensity Projection (MIP) - and to support: · Additional multi-channel technology coil for body - · Enhancement of PC board with new processor Maqnifico keeps all the other technological characteristics of the first cleared, version, as the 0.4T permanent Magnet, based on NdFeB (neodymium), C-shape.

The multifunctional ultrasound scanner MyLabX90 is used to collect, display, and analyze ultrasound images during ultrasound imaging procedures in combination with supported echographic probes. | Main application | Districts | Invasive access | |------------------|-------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------| | Cardiac | Cardiac Adult, Cardiac Pediatric | Transesophageal | | Vascular | Neonatal, Adult Cephalic, Vascular | Not applicable | | General Imaging | Abdominal, Breast, Musculo-<br>skeletal, Neonatal, Pediatric, Small<br>Organs (Testicles), Thyroid,<br>Urological | Intraoperative (Abdominal),<br>Laparoscopic,<br>Transrectal | | Women Health | OB/Fetal, Gynecology | Transrectal, Transvaginal | Virtual Navigator option supports a radiological clinical ultrasound examination (first modality) by providing additional image information from a second imaging modality. As second imaging modality it is intended any image coming from CT, MR, US, PET,XA and NM. The second modality provides additional security in assessing the morphology of the real time ultrasound image.

The upgraded 6440 systems, MyLabX90 is a mainframe systems equipped with wheels allowing to move the system. MyLabX90 scanners are based on a mainframe easily movable platform. MyLabX90 scanners have four swiveling wheels. they have a range of height adjustments for onetime installation, the main screen can be easily moved due to an optional articulated arm. Due to their small footprint they can fit in any real-world clinical environment. The possibility to adjust both the main screen. control panel and touchscreen brightness enables the use of MyLab in any environment even with really different lighting conditions: from the really bright scenario of the operative room, to the dark scenario of the examination room, passing through the medium-light environment of the bed-side examination setting. The primary modes of operation are for both models: B-Mode, M-Mode, Tissue Enhancement Imaging (TEI), Multi View (MView), Doppler, Color Flow Mapping (CFM), Amplitude Doppler (AD), Tissue Velocity Mapping (TVM), 3D and 4D. Model 6440 manages Qualitative Elastosonography (ElaXto). Model 6440 can drive Phased array, Convex array, Linear array, Doppler probes and Volumetric probes (Bi-Scan probes). The control panel is equipped with a pull-out Qwerty alphanumeric keyboard that allows data entry. Model 6440 has the Virtual Navigator software option integrated, designed to support a radiological clinical ultrasound examination (first modality) and follow a percutaneous procedure providing additional image information from a 2nd imaging modality (CT, MR, US and PET). The user is helped in assessing the patient anatomy by displaying the image generated by the 2nd modality. Model 6440 is equipped with wireless capability. Model 6440 is already cleared via K173291. The marketing name for new devices of Model 6440 will be: MyLabX90 ● MyLabX90, defined herein, combines the cleared features of 6440 system with new capabilities, listed below: - 1. Cardio Package with new AUTO E.F. The AutoEF, based on Artificial Intelligence, detects and track, automatically, the LV endocardial border to calculate LV Volumes (Diastolic Volume - Systolic Volume) and EF (Ejection Fraction). The software module (powered with A.I.) is registered by Pie Medical Imaging B.V. as Caas Qardia (K212376) - 2. eDetect for Breast Lesions contouring function supports the operator by detecting the lesion contour (with A.I. algorithm) in Breast measurements, after that the operator has identified the region, with suspicious lesions, and applied the ROI marker. At the end of the detection the operator can confirm/edit the proposed contour or redraw it completely. In addition, several morphologic parameters (following Bi-Rads : shape, orientation and circumscribed) are automatically proposed to the customer and upon validation is inserted in the final report. The tool is available in Breast application. - 3. XStrain allows clinicians to quantify endocardial velocities of contraction and relaxation and local deformation of the heart (Strain rate). Based on 2D speckle tracking technology with Angle-independent technology. A.I. Powered for auto border detection of left ventricle (LV). - 4. The QAI (Quality Attenuation Imaging) application allows to perform a Colored Quantitative Attenuation analysis of tissues in Real-time. Based on the attenuation analysis along the ROI. In QAI attenuation parameter values are converted and color coded and displayed inside the Region Of Interest (ROI). A different set of palettes is available, with dynamic control and transparency. - The Prostate Biopsy Stepper is enabling the compatibility with CIVCO Classic and GfM 5. MST50 steppers displaying a Grid Template overlays for precise guided-biopsies. The Stepper help stabilizes and follows accurate needle path during transperineal procedure. Stepper functionality is available in Fusion imaging / UroFusion environment. - HyperDoppler, based on Color Doppler Flow Mapping (CDFM) technology, provides different 6. map representation to highlight the intracardiac flow properties - 7. Transducer Element Check - 8. New transducers 2CWL, 5CWL, CX 1-8, LX 3-15, LMX 4-20, PX 1-5 and TE 3-8 - 9. New biopsy kits JSM-198 and JSM-113.

The general-purpose magnetic resonance imaging (MRI) system is designed to scan any targeted area of the body, to collect, display and analyse MR images and other real-time imaging procedures. Imaging portions of the upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, imaging portions of the lower limb, including the foot, ankle, calf, knee, thigh and hip, imaging the temporomandibular joint and imaging the cervical, the thoracic, the lumbar and the sacral sections as portions of the spinal column, imaging the pelvis and imaging the head. Outcomes related to diagnosis Magnifico is a Magnetic Resonance (MR) system that produces cross-section images of the limbs, joints, spinal column, pelvis and head. MRI provides better soft tissue contrast than CT and can differentiate better between fat, water, muscle, and other soft tissue than CT (CT is usually better at imaging bones). These images provide information to physicians and can be useful in diagnosing a wide variety of diseases and conditions.

Magnifico is a Magnetic Resonance (MR) system with two configurations: 1. Magnifico Open, "Whole body" configuration (all above listed, in intended use, anatomical regions) 2. Magnifico MSK, musculoskeletal configuration (all above listed anatomical regions, excluded head and pelvis) which produces images of the internal structures of the patient's limbs, joints and spinal column. The system comprises four main parts: - Patient Table - . Magnetic Unit, containing a permanent magnet - Console, comprising a PC, keyboard, mouse, monitor and operating table - Electronic box Magnifico has an open magnet that makes comfortable MRI exam for all patients, including claustrophobic patients, in particular children. Additionally, Magnifico comes with a transparent headcoil for enhanced patient comfort.

The multifunctional ultrasound scanner MyLabX75 Family is used to collect, display, and analyze ultrasound images during ultrasound imaging procedures in combination with supported echographic probes -Cardiac [Adult and Pediatric] -Vascular [Neonatal, Adult Cephalic, Vascular generic] -General Imaging [Abdominal, Breast, Musculo-skeletal, Neonatal, Pediatric, Small Organs (Testicles), Thyroid, Urological ] with invasive access Intraoperative (Abdominal), Laparoscopic, Transrectal. -Women Health [OB/Fetal, Gynecology with invasive access (Transrectal, Transvaginal)] The equipment provides imaging for guidance of biopsy and imaging to assist in the placement of needles and catheters in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications. The ultrasonic medical diagnostic equipment is intended to mechanical and electronic ultrasound probes (convex array, linear array and phased array) and Doppler probes. The Fiber Guidance option assists ultrasound guidance in the phases of insertion and positioning of the introducer needle and optical fiber and procedure monitoring.

Model 6430, commercial names MyLabX75 and MyLab XPro75, is a mainframe ultrasound system used to perform diagnostic general ultrasound studies. The primary modes of operation are: B-Mode, Tissue Enhancement Imaging (TEI), M-Mode, Multi View (MView), Doppler (both PW and CW), Color Flow Mapping (CFM), Amplitude Doppler (AD), Tissue Velocity Mapping (TVM), 3D and 4D, Qualitative Elastosonography (ElaXto) and Quantitative Elastosonography (QElaXto). Model 6430 has a software option integrated, called PLA, designed to support a radiological clinical ultrasound examination (first modality) and follow a percutaneous procedure providing additional image information from a second imaging modality (CT, MR, US and PET). The user is helped in assessing the patient anatomy by displaying the image generated by the 2nd modality. Model 6430 is equipped with a LCD color display where acquired images and advanced image features are shown. Model 6430 control panel is equipped with a pull-out Qwerty alphanumeric keyboard that allows data entry. The touchscreen has an emulation of the Qwerty alphanumeric keyboard that allows data entry and has additional controls and mode-depending keys, integrated in the touchscreen. Model 6430 can drive Phased Array (PA), Convex Array (LA), Linear Array (LA), Doppler and Volumetric probes. Model 6430 is equipped with an internal Hard Disk Drive. Data can also be stored directly to external archiving media (Hard-Disk, PC, on server) via a LAN/USB port. 6430 project is mainly design change of 6450 devoted to reducing cost and to differentiate design and performances, 6430 will introduce in the Esaote's Mid-ultrasound tier functionalities that, at the moment are present only in our High -End Ultrasound tier, such as 2D Shear Wave Elastography (2D-SWE) and Virtual Navigator. The marketing names for Model 6430 will be MyLabX75 and MyLab XPro75. The difference between MyLab XPro75 is only in the licenses configuration: on MyLab XPro75 all the options are included while in the MyLabX75 some licenses can be ordered by customer.

MyLabSigma is intended to perform diagnostic general ultrasound studies including: Fetal, Abdominal, Intraoperative (Abdominal), Laparoscopic, Pediatric, Small organs, Neonatal, Neonatal Cephalic, Adult Cephalic, Transvaginal, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Urological, Cardiovascular Adult, Cardiovascular Pediatric, Transoesophageal (cardiac), Peripheral Vessel. The equipment provides imaging for guidance of biopsy and imaging to assist in the placement of needles and catheters in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications. The ultrasonic medical diagnostic equipment is intended to mechanical and electronic ultrasound probes (convex array, linear array and phase array) and Doppler probes.

The upgraded 7410 system (MyLabSigma), is a portable system equipped with a handle. The system sizes and weights allow them to be carried using its handle. The primary modes of operation are: B-Mode, M-Mode, Tissue Enhancement Imaging (TEI), Multi View (MView), Doppler, Color Flow Mapping (CFM), Amplitude Doppler (AD), Tissue Velocity Mapping (TVM), 3D and 4D. Model 7410 is equipped with a LCD color display where acquired images and advanced image features are shown. Model 7410 can drive Phased array. Linear array. Doppler probes and Volumetric probes (Bi-Scan probes). The control panel is equipped with a touchscreen that has an emulation of the Qwerty alphanumeric keyboard that allows data entry. Model 7410 is equipped with wireless capability. Model 7410 is already cleared via K161359. The marketing name for new devices of Model 7410 will be: - MyLabSigma ● MyLabSigma, defined herein. combine the cleared features of 7410 system with new capabilities, listed below: - Addition of Auto NT (Automatic Nuchal Translucency) option, allows to automatically capture Nuchal Translucency measurement. - Addition of Auto EF (Automatic Ejection Fraction) option, allows to automatically capture Ejection Fraction measurement. - . Management of probes L3-11, L4-15, mC 3-11 and P2 3-11. - . Full screen option. - . Windows 10 Operative System. The 7410 new version is manufactured under a quality system compliance with 21CFR 820 requirements and certified according to ISO 9001:2015 and ISO 13485:2016.

Esaote 7400, MyLabOmega, is a compact portable system intended to perform diagnostic general ultrasound studies including: Fetal, Abdominal, Intraoperative (Abdominal), Laparoscopic, Pediatric, Small organs, Neonatal, Neonatal Cephalic, Adult Cephalic, Transvaginal, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Urological, Cardiovascular Adult, Cardiovascular Pediatric, Transoesophageal (cardiac), Peripheral Vessel. The equipment provides imaging for guidance of biopsy and imaging to assist in the placement of needles and catheters in vascular, or other anatomical structures, as well as peripheral nerve blocks in Musculoskeletal applications. The ultrasonic medical diagnostic equipment is intended to be connected to mechanical and electronic ultrasound probes (convex array, linear array and phased array) and Doppler probes.

The upgraded 7400 system (MyLabOmega) is portable systems equipped with a handle. The system sizes and weights allow them to be carried using its handle. The primary modes of operation are for both models: B-Mode, M-Mode, Tissue Enhancement Imaging (TEI), Multi View (MView), Doppler, Color Flow Mapping (CFM), Amplitude Doppler (AD), Tissue Velocity Mapping (TVM), 3D and 4D. Model 7400 manages Qualitative Elastosonography. 7400 is equipped with a LCD color display where acquired images and advanced image features are shown. 7400 can drive Phased, Convex, Linear array, Doppler probes and Volumetric probes (Bi-Scan probes). On both models the touchscreen has an emulation of the Qwerty alphanumeric keyboard that allows data entry. 7400 model is equipped with wireless capability and has been designed to be powered by battery. The upgraded 7400 system, defined herein, combines the cleared features of both the 6440 and 7400 systems with new capabilities, listed below: - 1. Addition of Auto NT option. - 2. Addition of MicroV option. - 3. Addition of Qpack option. - 4. Management of probe P 1-5. - 5. Management of probe L 4-15 - 6. Addition of 4D Stic option. - 7. Addition of Full screen option. - 8. Operative system Windows 10

O-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal, coronal and oblique section images of limbs and joints. It is designed for imaging portions of the arm, including hand, wrist, forearm, and elbow, but excluding the upper part of the arm and portions of the leg, including foot, ankle, calf, and knee, but excluding the thigh. The M.R. images produced by O-scan correspond to the spatial distribution of the protons (hydrogen nuclei) which verify the properties of magnetic resonance and depend on the MR parameters spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nucleus density, flow velocity and "chemical shift". When interpreted by a medical expert trained in use of MR equipment, the images can provide diagnostically useful information.

The changes performed on the modified O-scan, with respect to the cleared version – O-scan K092469 are due to the upgrade of the software system. These modifications, which do not affect the intended use or alter the fundamental scientific technology of the device, are the following: - A new Software version (EVO'18) including the following features: - 1. AGilExam (automatic slice positioning for the examination of the anatomical regions of knee, ankle and wrist) - 2. 3D Viewer; this is an option that starting from the acquired data cube allows the running of a 3D viewer in which to reconstruct the desired 3D series, both using the three projections of the acquired package and generating a special MPR curve as reference. (Previously cleared by FDA via K180592 on G-Scan Brio)

G-scan Brio is a Magnetic Resonance (MR) system that produces transversal, sagittal and coronal and oblique crosssection images of the head, limbs, joints and spinal column. It is intended for imaging portions of the upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, imaging portions of the lower limb, including the foot, ankle, calf, knee, thigh and hip, imaging the temporomandibular joint and imaging the cervical, the thoracic and the lumbosacral sections as portions of the spinal column. G-scan Brio images correspond to the spatial distribution of protons (hydrogen nuclei) that determine magnetic resonance properties and are dependent on the MR parameters, including spin-lattice (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a medical expert trained in use of MR equipment, the images can provide diagnostically useful information.

The changes performed on the modified G-scan Brio, with respect to the cleared version – G-scan Brio K161973 – are due to the upgrade of the software system. These modifications, which do not affect the intended use or alter the fundamental scientific technology of the device, are the following: - A new Software version (EVO'17) including the following features: - o New software feature Q-Spine (Quantitative Spine) - o New software feature 3D Viewer - o The availability of the E-MRI viewer eXP, the software used as an extension on PC. Esaote has decided to develop and release an upgrade for software EVO. The EVO'17 includes two new features Q-Spine and 3D Viewer. The function Q-Spine has been already cleared by FDA under the name OrthoCAD System via K120288. The function 3D Viewer has been already cleared by FDA under the name 3Viseon/Surgery via K072653. E-MRI viewer eXP, the software used as an extension on PC, is equivalent to E-MRI Brio Viewer, which is currently available on the G-Scan Brio MRI systems, cleared via K161973.