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Velacur is intended to provide estimates of tissue stiffness generated from shear wave speed measurements (40-70 Hz), ultrasound attenuation and Velacur Determined Fat Fraction (VDFF). The Velacur Determined Fat Fraction combines ultrasound attenuation and backscatter coefficient measurements. The device is indicated to non-invasively determine liver tissue stiffness, attenuation, and Velacur Determined Fat Fraction. VDFF is not intended to be used in pediatric patients. These are meant to be used in conjunction with other clinical indicators in order to aid in clinical management of patients with liver diseases, including hepatic steatosis. The device is intended to be used in a clinical setting and by trained medical professionals.

The device that is the subject of this submission is the substantially equivalent to that cleared under K233977, Velacur. Velacur ONE is a portable device intended to non-invasively measure the stiffness and attenuation of the liver via measurement of liver tissue shear modulus and ultrasound attenuation. This is done by measuring the wavelength or wave speed of mechanically created shear waves within the organ of the patient. Attenuation is measured directly via the loss in power of the ultrasound beam and Velacur Determined Fat Fraction is a combination of measured ultrasound attenuation and backscatter. The device is designed to be used at the point of care, in clinics and hospitals. The device is used by a medical profession, an employee of the clinic/hospital. The activation unit is placed under the patient, while lying supine on an exam bed. The activation unit vibrates at frequencies 40, 50, and 60 Hz causing shear waves within the liver of the patient. The ultrasound transducer is placed on the patient's skin, over the intercostal space, and is used to take volumetric scans of the liver while shear waves are occurring. The device includes two algorithms designed to help users detect good quality shear waves and identify liver tissue. From the scan data, the device calculates tissue stiffness and attenuation. Software and hardware changes were made to the device. The intended use of the device is unchanged. The user interface was updated to a more modern platform with the same workflow and outputs. The hardware components have been consolidated, combining the functionality of the computing unit and control unit. The activation unit has been designed to include more voice coils which are distributed throughout the unit. The power output and performance of the activation unit is unchanged.

The Accuro 3S is a diagnostic ultrasound imaging system for use by qualified and trained healthcare professionals. Accuro 3S is intended to be used in a hospital or medical clinic environment at the point of care. Accuro 3S supports B-mode imaging and a SpineNav-AI™ image processing software. Accuro 3S clinical applications include: musculoskeletal conventional and superficial, and guidance for needle or catheter placement. A typical examination using Accuro 3S is guidance of neuraxial anesthesia.

The Accuro® 3S is an ultrasound imaging device intended for use by qualified and trained healthcare professionals in hospital or medical clinic environments. The device offers B-mode imaging and a SpineNav-AI™ image processing software. The Accuro 3S is a portable system with a small footprint that can be easily maneuvered within the intended use environment and at the point of care. The device features a touchscreen interface and articulated monitor arm to optimize viewing angle. An integrated battery pack allows the system to operate without wall power. Accuro 3S interfaces with healthcare IT networks to implement DICOM-based patient and image archival workflows, with image storage in an external PACS. The device utilizes a Dual-Array™ convex probe. SpineNav-AI is an automated software tool that utilizes machine learning technologies to facilitate workflows associated with musculoskeletal imaging assessments of the lumbar spine. The Accuro 3S Dual-Array probe comprises a side-by-side convex transducer array design. Each convex array has identical specifications: 64 elements, 3.5 – 4.0 MHz nominal center frequency, 480-micron pitch, and 50 mm radius of curvature.

EchoGuide is a vascular ultrasound imaging device meant to aid in identification of the cannulation site on the skin of mature arteriovenous fistulas/grafts (AVFs/AVGs) in adult patients by appropriately trained healthcare providers in clinical settings. This device is not meant to replace the current standard of care cannulation methods.

EchoGuide is a 3D automated ultrasound solution designed to provide the benefits of ultrasound for arteriovenous fistula/graft cannulation without the need for extensive training. EchoGuide uses a three-dimensional probe to acquire live coronal plane images, in addition to automating imaging settings, to allow users to quickly assess the position, trajectory, and size of an arteriovenous fistula/graft. Users can then mark the position and trajectory of the access on the patient's skin before removing the probe and proceeding with cannulation. The EchoGuide probe houses a 2D array on a track. The piezoelectric material in the transducer is used as an ultrasound source to transmit sound waves into the body. Sound waves are reflected back to the transducer and converted to electrical signals that are processed. The transducer is a 52 mm linear (192 element) motorized probe capable of capturing a volume of data. The motorized probe collects a series of 2D images to capture a volume. Through image analysis and processing, the volumes are sliced to create live coronal plane renderings. The ultrasound system has a laptop form factor, with a bottom touch screen for user interaction and an additional top screen for display. The ultrasound system includes a transmitter and receiver, are all self-contained within the case. The ultrasound system interfaces with the probe through a port on the right side of the system. The EchoGuide user interface defaults to a conventional 2D ultrasound image when the system powers on. Users can switch between this view, and the live coronal imaging via controls on the bottom screen of the ultrasound. Users can freeze the imaging and capture a snapshot of the fistula/graft as well. The snapshot displays a static view of the fistula/graft in the coronal and transverse planes. EchoGuide is intended to be used in a clinical setting at the point of hemodialysis care.

The Liverscan C is intended to provide shear wave speed measurements and estimates of tissue stiffness as well as ultrasound coefficient of attenuation (MAP: Mobile Attenuation Parameter) in internal structures of the body. The shear wave speed and stiffness measurements may be used as an aid to clinical management of adult patients with liver disease. The Liverscan C is indicated for non-invasive measurement in the liver of 50 Hz shear wave speed and estimates of stiffness as well as determining a 3.5MHz ultrasound coefficient of attenuation (MAP: Mobile Attenuation Parameter). The shear wave speed and stiffness, and MAP may be used as an aid to diagnosis and monitoring of adult patients with liver disease, as part of an overall assessment of the liver. This device is designed to be used in a doctor's office to measure the stiffness and ultrasonic attenuation of the liver in patients with liver disease. It does so in a painless and completely noninvasive manner.

The Liverscan C is intended to provide shear wave speed measurements and estimates of tissue stiffness as well as ultrasound coefficient of attenuation (MAP: Mobile Attenuation Parameter) in internal structures of the body. The shear wave speed and stiffness measurements may be used as an aid to clinical management of adult patients with liver disease. The Liverscan C is indicated for non-invasive measurement in the liver of 50 Hz shear wave speed and estimates of stiffness as well as determining a 3.5MHz ultrasound coefficient of attenuation (MAP: Mobile Attenuation Parameter). The shear wave speed and stiffness, and MAP may be used as an aid to diagnosis and monitoring of adult patients with liver disease, as part of an overall assessment of the liver.

The SpineUs™ system is a software-based, tracked, ultrasound imaging system and accessories, intended for diagnostic imaging. It is indicated for diagnostic ultrasound imaging in the following applications: musculoskeletal (conventional, superficial). The system is intended for use by trained chiropractors and radiologists in a hospital or medical clinic. The SpineUs™ system is intended for assisting trained chiropractors and radiologists in acquiring, viewing, and measuring ultrasound images of the spine in both clinic and hospital settings. The SpineUs™ system is intended to be used as an adjunct to conventional imaging method that allows trained chiropractors and radiologists to measure spine-related anatomical components on images (e.g., intervertebral angles and spine curvature). The system also allows the review and management of patient measurement data. Clinical judgment of anatomy and experience are required to properly use the SpineUs™ system. Patient management decisions should not be made based solely on the results of the SpineUs™ computer application. The user shall retain the ultimate responsibility of ascertaining the measurements based on standard practices and clinical judgement.

The SpineUs™ System is a diagnostic ultrasound system, which consists of the FDA cleared Clarius Ultrasound Scanner C3 HD3 (K213436), a consumer PC, a tracking system with OptiTrack cameras connected to a POE switch and active LED markers, and the SpineUs™ computer application. The SpineUs™ computer application, installed in the consumer PC, processes the ultrasound imaging data received from the Clarius Ultrasound Scanner and the tracking data received from the tracking system. The SpineUs™ computer application allows the operator to view ultrasound images of the spine, segment the ultrasound images using artificial intelligence, generate and visualize 3D reconstructions of the surface of the spine in real-time, measure spine-related anatomical components (e.g., intervertebral angles and spine curvature), review and manage patient measurement data, and generate and export printable reports. The SpineUs™ system comprises the following: Transducer / Scanner: Clarius Ultrasound Scanner, model C3 HD3 (K213436) Software: SpineUs™ computer application Tracking system: Motive Software, OptiTrack Cameras, SpineUs™ Active LED Markers, Power over Ethernet (PoE) switch Accessories: USB-C charging cables, USB-C charging block, Wall mounted camera holders/covers, Tracker Reference (includes belt), Consumer PC

Velacur is intended to provide estimates of tissue stiffness generated from shear wave speed measurements (40-70 Hz), ultrasound attenuation and Velacur Determined Fat Fraction (VDFF). The Velacur Determined Fat Fraction combines ultrasound attenuation and backscatter coefficient measurements. The device is indicated to non-invasively determine liver tissue stiffness, attenuation, and Velacur Determined Fat Fraction. VDFF is not intended to be used in pediatric patients. These are meant to be used in conjunction with other clinical indicators in order to aid in clinical management of patients with liver diseases, including hepatic steatosis. The device is intended to be used in a clinical setting and by trained medical professionals.

Velacur is a portable device intended to non-invasively measure the stiffness and attenuation of the liver via measurement of liver tissue shear modulus and ultrasound attenuation. This is done by measuring the wavelength or wave speed of mechanically created shear waves within the orqan of the patient. Attenuation is measured directly via the loss in power of the ultrasound beam. The device is designed to be used at the point of care, in clinics and hospitals. The device is used by a medical profession, an employee of the clinic/hospital. The activation unit is placed under the patient, while lying supine on an exam bed. The activation unit vibrates at frequencies 40, 50, and 60 Hz causing shear waves within the liver of the patient. The ultrasound transducer is placed on the patient's skin, over the intercostal space, and is used to take volumetric scans of the liver while shear waves are occurring. The device includes two algorithms designed to help users detect good quality shear waves and identify liver tissue. From the scan data, the device calculates tissue stiffness and attenuation. Minor hardware and software changes were made to the organ guide (cleared in K223287) was also extended to add more optional overlays on top of the liver overlay to help with optimizing the scan and training users to obtain adequate images. The significant change is the addition of a new output measure for Velacur, an ultrasound derived fat fraction (VDFF).

The SC1 Ultrasound Imaging System (Model: SC1) is intended for diagnostic ultrasound echo imaging, measurement, and analysis of the human body for general clinical applications including musculoskeletal (MSK), vascular, small parts (breast, thyroid) through B mode. Flow detection is possible using PWD (Power Doppler) mode. SC1 is a transportable ultrasound system intended for use in environments where healthcare is provided by healthcare professionals.

The SC1 Handheld ultrasound imaging system, Model: SC1, is a general purpose, software-controlled, diagnostic ultrasound system that uses pulsed-echo technology (B Mode (Power Doppler); Frequency: 5 - 13 MHz; module: linear; depth max: 10 cm) to transmit ultrasound images via wired communication to a mobile device that utilizes the Android operating system. Its function is to acquire ultrasound data and to display the data in operation. The SC1 Handheld ultrasound imaging system is a portable, general-purpose, software-controlled, hand-held diagnostic ultrasound system that consists of (i) the battery-operated, SC1L (Linear type Ultrasound Probe) that communicates wired with Android mobile device, (ii) the software that runs as an app on the mobile device, (iii) batteries, charger (Cradle), cable, power cord, and magnetizers (option), (iv) the instructions for use manual. The SC1 App software can be downloaded to an Android mobile device and utilizes an icon touch-based user interface. The software enables ultrasound image review, controls for depth, gain, linear measurement. The SC1 App software allows the user to image in real time and review freeze-frame images on the screen in a B-Mode and PD-Mode, 2-dimensional scan format. SC1 Handheld ultrasound system is only intended for acquisition and real time diagnosis. SC1 Handheld ultrasound system (SC1 probe and SC1 app) provides functions on patient data (entering new patient information, editing patient data saving, storing, or transferring patient information). It is possible to connect to the PACS DICOM network (hospital network) to get the list of exams and export recorded exams. However, there is no option to export patient data via a USB cable. Physician who is responsible for interpreting ultrasound images must be available in the room to provide diagnosis in real time. SC1 Handheld ultrasound imaging system utilizes pulsed-echo technology to determine the depth and location of tissue interfaces, and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. Ultrasound waves are emitted from the transducer, propagate through tissues, and return to the transducer as reflected echoes. The returned echoes are then converted into electrical impulses by transducer crystals and further processed in order to form the ultrasound image presented on the screen. The device components are not supplied sterile and do not require sterilization prior to use.

The ACUSON SC2000 Diagnostic Ultrasound System is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Abdominal, Intraoperative Abdominal, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The ACUSON SC2000 Diagnostic Ultrasound System is a multi-purpose diagnostic ultrasound system with proprietary software and accessories. The function of the ACUSON SC2000 Diagnostic Ultrasound System is to transmit, receive, process ultrasound echo data (distance and intensities information about body tissue) in various modes of operation and display it as ultrasound imaging, measurements, calculations, analysis of the human body and fluid flow, etc.

B-Ultrasound Diagnostic System in a general-purpose, digital ultrasound diagnostic system for abdomen, gynecology, obstetric, urology, and small-parts application. The system is intended to use for the following type of studies: fetal organ, abdominal, pediatric, small organs (Thyroid, Galactophore, Testis), neonatal cephalic, peripheral vasculo-skeletal (both conventional and superficial), The device is intended to adult, pregnant woman, pediatric and neonate. The system is a prescription device intended to be used by or on the order of a physician or similar qualified health care professional. This device is not intended for home use. Modes of operation include B, M, PWD(PW), B+M, 2B, 4B.

B-Ultrasound Diagnostic System in a general-purpose, digital ultrasound diagnostic system for abdomen, gynecology, obstetric, urology, and small-parts application. The system is intended to use for the following type of studies: fetal organ, abdominal, pediatric, small organs, neonatal cephalic, peripheral vascular, and musculo-skeletal (both conventional and superficial). The device is intended to adult, pregnant woman, pediatric and neonate. The system is a prescription device intended to be used by or on the order of a physician or similar qualified health care professional. This device is not intended for home use. Modes of operation include B, M, PWD(PW), B+M, 2B, 4B. Please refer to the acoustic output declaration for each transducer as following pages. B-Ultrasound Diagnostic System is a Track 3, diagnostic ultrasound system, which has a main unit and two probes (Broadband convex array probe and Broadband convex array probe), powered by a 14.4V lithium battery, the ultrasonic signal is continuously transmitted at a frequency of 2-12MHz. The B-Ultrasound Diagnostic System of six functional modules: Power module, Ultrasound front-end module, Keyboard module, Industrial control board, LCD screen, and Interface board. When electrical pulses are applied to the piezoelectric wafer (transducer), it will produce ultrasound waves of a certain frequency, which will enter the human body. Due to the ultrasound waves traveling through different tissues in the human body with different acoustic impedances (caused by differences in density and ultrasound transmission speed), the reflected echoes generated by the surfaces of different organs in the human body will be different. The reflected echoes of different sizes will be received by the piezoelectric wafer, and then converted into electrical pulse signals. After digital beamforming and other processing, those signals are formed into standard video signals that can be displayed on the monitor screen as cross-sectional images of the organ.