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Clarius Median Nerve AI is intended for segmentation and semi-automatic non-invasive measurements of the median nerve cross-sectional area on ultrasound data acquired by the Clarius Ultrasound Scanner (i.e., linear array scanners). The user shall be a healthcare professional trained and qualified in ultrasound. The user retains the responsibility of confirming the validity of the measurements based on standard practices and clinical judgment. Clarius Median Nerve Al is indicated for use in adult patients only.

Clarius Median Nerve AI is a machine learning algorithm that is integrated into the Clarius App software as part of the complete Clarius Ultrasound Scanner system for use in musculoskeletal ultrasound applications, specifically intended for segmentation and measurement of the cross-sectional area of the median nerve. Clarius Median Nerve AI is intended for use by trained healthcare practitioners for measurement of the cross-sectional area (CSA) of the median nerve on ultrasound data acquired by the Clarius Ultrasound Scanner system (i.e., linear array scanners) using a deep learning image segmentation algorithm. During the ultrasound imaging procedure, the anatomical site is selected through a preset software selection (i.e., Hand/Wrist) from the Clarius App in which Clarius Median Nerve AI will segment the median nerve in transverse view (with a segmentation mask placed on the ultrasound image) and engage to automatically place calipers on the segmentation mask to measure the median nerve's cross-sectional area. Clarius Median Nerve AI operates by performing the following tasks: • Automatic detection and measurement of the median nerve in transverse view Clarius Median Nerve AI operates by identifying and segmenting the median nerve in the forearm and wrist and performs automatic measurements of the median nerve's cross-sectional area. The user has the option to manually adjust the measurements made by Clarius Median Nerve AI by moving the caliper crosshairs. Clarius Median Nerve AI does not perform any functions that could not be accomplished manually by a trained and qualified user. Clarius Median Nerve AI is an assistive tool intended to inform clinical management and is not intended to replace clinical decision-making. The clinician retains the ultimate responsibility of ascertaining the measurements based on standard practices and clinical judgment. Clarius Median Nerve AI is indicated for use in adult patients only. Clarius Median Nerve AI is integrated into the Clarius App software, which is compatible with iOS and Android operating systems two versions prior to the latest iOS or Android stable release build and is intended for use with the following Clarius Ultrasound Scanner system transducers (previously 510(k)-cleared in K213436). Clarius Median Nerve AI is not a stand-alone software device.

Clarius Prostate AI is intended for semi-automatic measurements of prostate volume on ultrasound data acquired by the Clarius Ultrasound Scanner (i.e., curvilinear and endo-cavitary scanners). The user shall be a healthcare professional trained and qualified in ultrasound. The user retains the responsibility of confirming the validity of the measurements based on standard practices and clinical judgment. Clarius Prostate AI is intended for use in adult male patients only.

Clarius Prostate AI is a machine learning algorithm that is integrated into the Clarius App software as part of the comprehensive Clarius Ultrasound Scanner system for use in prostate ultrasound imaging applications. Clarius Prostate AI is intended for use by trained healthcare practitioners for measurement of prostate volume on ultrasound data acquired by the Clarius Ultrasound Scanner system (i.e., curvilinear and endo-cavitary scanners) using a deep learning image segmentation algorithm. During the ultrasound imaging procedure, the anatomical site is selected through a preset software selection (i.e., Prostate) from the Clarius App in which Clarius Prostate AI will engage to segment the prostate gland and place calipers for measurement of prostate volume. Clarius Prostate AI operates by performing the following tasks: - Automatic detection and measurement of prostate length - Automatic detection and measurement of prostate width - Automatic detection and measurement of prostate height - Automatic detection of the corresponding image view Clarius Prostate AI operates by performing automatic measurements of prostate height, width, and length, and calculates prostate volume. The user has the option to manually adjust the measurements made by Clarius Prostate AI by moving the caliper crosshairs. Clarius Prostate AI does not perform any functions that could not be accomplished manually by a trained and qualified user. Clarius Prostate AI is intended for use in B-Mode only. Clarius Prostate AI is an assistive tool intended to inform clinical management and is not intended to replace clinical decision-making. The clinician retains the ultimate responsibility of ascertaining the measurements based on standard practices and clinical judgment. Clarius Prostate AI is indicated for use in adult male patients only. Clarius Prostate AI is integrated into the Clarius App software, which is compatible with iOS and Android operating systems two versions prior to the latest iOS or Android stable release build and is intended for use with the following Clarius Ultrasound Scanner system transducers (previously 510(k)-cleared in K213436). Clarius Prostate AI is not a stand-alone software device.

Clarius OB Al is intended to assist in measurements of fetal biometric parameters (i.e., head circumference, abdominal circumference, femur length, bi-parietal diameter, crown rump length) on ultrasound data acquired by the Clarius Ultrasound Scanner (i.e., curvilinear scanner). The user shall be a healthcare professional trained and qualified in ultrasound. The user retains the responsibility of confirming the validity of the measurements based on standard practices and clinical judgment. Clarius OB Al is indicated for use in adult patients only.

Clarius OB Al is a machine learning algorithm that is incorporated into the Clarius App software as part of the complete Clarius Ultrasound Scanner system for use in obstetric (OB) ultrasound imaging applications. Clarius OB Al is intended for use by trained healthcare practitioners for non-invasive measurements of fetal biometric parameters on ultrasound data acquired by the Clarius Ultrasound Scanner system (i.e., curvilinear scanner) using a deep learning image segmentation algorithm. During the ultrasound imaging procedure, the anatomical site is selected through a preset software selection (i.e., OB, Early OB) within the Clarius App in which Clarius OB Al will engage to segment the fetal anatomy and place calipers for measurement of fetal biometric parameters. Clarius OB Al operates by performing the following tasks: - Automatic detection and measurement of head circumference (HC) - Automatic detection and measurement of abdominal circumference (AC) - Automatic detection and measurement of femur length (FL) - Automatic detection and measurement of bi-parietal diameter (BPD) - Automatic detection and measurement of crown rump length (CRL) Clarius OB Al operates by performing automatic measurements of fetal biometric parameters. The user has the option to manually adjust the measurements made by Clarius OB Al by moving the caliper crosshairs. Clarius OB Al does not perform any functions that could not be accomplished manually by a trained and qualified user. Clarius OB AI is intended for use in B-Mode only. Clarius OB Al is an assistive tool intended to inform clinical management and is not intended to replace The clinician retains the ultimate responsibility of ascertaining the clinical decision-making. measurements based on standard practices and clinical judgment. Clarius OB Al is indicated for use in adult patients only. Clarius OB Al is incorporated into the Clarius App software, which is compatible with iOS and Android operating systems two versions prior to the latest iOS or Android stable release build and is intended for use with the following Clarius Ultrasound Scanner system transducer (previously 510(k)-cleared in K213436). Clarius OB Al is not a stand-alone software device.

Clarius Bladder AI is intended for semi-automatic non-invasive measurements of bladder volume on ultrasound data acquired by the Clarius Ultrasound Scanner (i.e., curvilinear and phased array scanners). The user shall be a healthcare professional trained and qualified in ultrasound. The ultimate responsibility of ascertaining the measurements based on standard practices and clinical judgment. Clarius Bladder AI is indicated for use in adult patients only.

Clarius Bladder AI is a radiological (ultrasound) image processing software application which implements artificial intelligence (Al), utilizing non-adaptive machine learning algorithms, and is incorporated into the Clarius App software for use as part of the complete Clarius Ultrasound Scanner system product offering in bladder ultrasound imaging applications. Clarius Bladder Al is intended for use by trained healthcare practitioners for non-invasive measurements of bladder volume on ultrasound data acquired by the Clarius Ultrasound Scanner system (i.e., curvilinear and phased array scanners) using an artificial intelligence (AI) image segmentation algorithm. During the ultrasound imaging procedure, the anatomical site (bladder) is selected through a preset software selection (i.e., bladder) within the Clarius App in which Clarius Bladder Al will engage to segment the bladder and place calipers for calculation of bladder volume. Clarius Bladder Al operates by performing the following automations: - . Automatic detection and measurement of bladder depth - . Automatic detection and measurement of bladder width - . Automatic detection and measurement of bladder height - . Automatic detection of the corresponding image view (sagittal vs. transverse) Clarius Bladder Al operates by performing automatic measurements of bladder height, width, and length, and calculates bladder volume. The user has the option to manually adjust the measurements made by Clarius Bladder Al by moving the caliper crosshairs. Clarius Bladder Al does not perform any functions that could not be accomplished manually by a trained and qualified user. Clarius Bladder Al is intended for use in B-Mode only. Clarius Bladder AI is an assistive tool intended to inform clinical management and is not intended to replace clinical decision-making. The clinician retains the ultimate responsibility of ascertaining the measurements based on standard practices and clinical judgment. Clarius Bladder Al is indicated for use in adult patients only. Clarius Bladder AI is incorporated into the Clarius App software, which is compatible with iOS and Android operating systems two versions prior to the latest iOS or Android stable release build and is intended for use with the following Clarius Ultrasound Scanner system transducers (previously 510(k)-cleared in K213436). Clarius Bladder Al is not a stand-alone software device.

The Clarius Ultrasound Scanner is a software-based ultrasound imaging system and accessories, intended for diagnostic imaging. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: ophthalmic, fetal, abdominal, intra-operative (non-neurological), pediatric, small organ, cephalic (adult), trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), urology, cardiac (adult, pediatric), peripheral vessel, carotid, and procedural guidance of needles into the body. The system is a transportable ultrasound system intended for use in environments where is provided by trained healthcare professionals.

The Clarius Ultrasound Scanner is a portable, general-purpose, software-controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through an off-the-shelf (OTS) iOS or Android device. The Clarius Ultrasound Scanner comprises a series of wireless transducers employing Bluetooth and Wi-Fi-based technology to communicate with traditional tablet/smartphone devices via direct Wi-Fi. This allows the user to export ultrasound images and display them across a range of portable personal devices. The Clarius Ultrasound Scanner system is a transportable ultrasound system intended for use in environments where healthcare is provided by trained healthcare professionals, including the emergency medical services (EMS) environment. The Clarius Ultrasound Scanner is intended for use by qualified healthcare practitioners (e.g., doctors, nurses, sonographers) who are trained in the use of ultrasound imaging technology. The Clarius Scanner PAL HD3 ("PAL HD3") (subject device of this 510(k) premarket notification) is a multipurpose dual-array transducer that incorporates high-frequency linear array (equivalent to the L15 HD3 transducer cleared under K213436)) and low-frequency phased array (equivalent to the PA HD3 transducer cleared under K213436) ultrasound functionalities where the two separate transducer ceramics are arranged side-by-side within the same transducer model (PAL HD3). The Clarius Scanner PAL HD3 is a new Clarius HD3 transducer variant introduced into the HD3 product line of the Clarius Ultrasound Scanner device family and represents a design modification to the existing PA HD3 transducer of the Clarius Ultrasound Scanner system, which was most recently 510(k)-cleared under K213436. The Clarius Scanner PAL HD3 has two separate transducer ceramics positioned side-by-side which consist of the linear array and the phased array. The Clarius Scanner PAL HD3 offers a wide frequency range of 1 – 15 MHz within a single transducer. The body and electronics of the PAL HD3 scanner are identical to the currently released HD3 scanner models (the PA HD3 and the L15 HD3) of the Clarius Ultrasound Scanner device family (cleared under K213436); the main difference is in the scanner head. The Clarius Scanner PAL HD3 will allow clinicians to switch between the phased array and the linear array without having to use two separate scanners during exams and procedures. The Clarius Ultrasound Scanner, subject of this 510(k) premarket notification, comprises the following: Transducer/ Scanner: PAL HD3 Software: Clarius Ultrasound App (Clarius App) for iOS; Clarius Ultrasound App (Clarius App) for Android Accessories: Clarius Charger HD3; Clarius Power Fan HD3

Clarius AI is intended to semi-automatically place calipers for non-invasive measurements of musculoskeletal structures (e.g., Achilles' tendon, plantar fascia, patellar tendon) on ultrasound data acquired by the Clarius Ultrasound Scanner (i.e., L 7 and L15). The user shall be a healthcare professional trained and qualified in MSK (musculoskeletal) ultrasound. The user shall retain the ultimate responsibility of ascertaining the measurements based on standard practices and clinical iudgment.

Clarius AI is a radiological (ultrasound) image processing software application which implements artificial intelligence (Al), including non-adaptive machine learning algorithms, and is incorporated into the Clarius App software for use as part of the complete Clarius Ultrasound Scanner system product offering in musculoskeletal (MSK) ultrasound imaging applications. Clarius Al (MSK model) is intended for use by trained healthcare practitioners for non-invasive measurements of ultrasound data from musculoskeletal (MSK) ultrasound imaging acquired by the Clarius Ultrasound Scanner system using an artificial intelligence (AI) image segmentation algorithm. Clarius AI (MSK model) is intended to semi-automatically place adjustable calipers and provide supplementary information to the user regarding tendon thickness measurements (i.e., foot/plantar fascia, ankle/Achilles' tendon, knee/patellar tendon). Clarius Al is intended to inform clinical management and is not intended to replace clinical decision-making. The clinician retains the ultimate responsibility of ascertaining the measurements based on standard practices and clinical judgment. Clarius Al is indicated for use in adult patients only. During the ultrasound imaging procedure, the anatomical site is selected through a preset software selection (e.g., foot, ankle, knee), in which the Clarius Al will engage to segment the correlating tendon. Clarius Al analyzes ultrasound images in real-time and outputs probabilities for each pixel within the image for determination of the particular tendon thickness. The combination of all the pixels meeting a programmed threshold will render an overlay being displayed on top of the ultrasound image with a pre-programmed transparency so that the ultrasound greyscale is still visible. Once the user has obtained the best view, imaging can be manually paused, in which the Clarius Al will further analyze the tendon segmentation to determine the greatest thickness, in number of pixels, and subsequently place two measurement calipers that correspond to the top and bottom of the tendon at its thickest region, outputting a value in millimeters. The user can then manually alter the measurement calipers to make any necessary adjustments if desired. Clarius Al does not perform any functions that could not be accomplished manually by a trained and qualified user. Clarius AI (MSK model) is incorporated into the Clarius App software and is intended for use with the following Clarius Ultrasound Scanner system transducers (previously 510(k)-cleared in K180799, K192107, and K213436): Clarius Ultrasound Transducers: L7 and L15 Clarius App Software: Clarius Ultrasound App (Clarius App) for iOS; Clarius Ultrasound App (Clarius App) for Android

The Clarius Ultrasound Scanner is a software-based ultrasound imaging system and accessories, intended for diagnostic imaging. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: ophthalmic, fetal, abdominal, intra-operative (non-neurological), pediatric, small organ, cephalic (adult), trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), urology, gynecology, cardiac (adult, pediatric), peripheral vessel, carotid, and procedural guidance of needles into the body. The system is a transportable ultrasound system intended for use in environments where healthcare is provided by trained healthcare professionals.

The Clarius Ultrasound Scanner is a portable, general-purpose, software-controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through an off-the-shelf (OTS) iOS or Android device. The Clarius Ultrasound Scanner comprises a series of wireless transducers employing Bluetooth and Wi-Fi-based technology to communicate with traditional tablet/smartphone devices via direct Wi-Fi. This allows the user to export ultrasound images and display them across a range of portable personal devices. The system is a transportable ultrasound system intended for use in environments where is provided by trained healthcare professionals, including the emergency medical services (EMS) environment. The Clarius Ultrasound Scanner comprises the following: Transducers/ Scanners (various models): C3 HD3, C7 HD3, EC7 HD3, L7 HD3, L15 HD3, PA HD3, L20 HD3 Software: Clarius Ultrasound App (Clarius App) for iOS; Clarius Ultrasound App (Clarius App) for Android Accessories: Clarius Charger, Clarius Fan

The Clarius Ultrasound Scanner is a software-based ultrasound imaging system and accessories, intended for diagnostic imaging. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: ophthalmic, fetal, abdominal, intra-operative (non-neurological), pediatric, small organ, cephalic (adult), trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), urology, gynecology, cardiac (adult, pediatric), peripheral vessel, carotid, and procedural guidance of needles into the body. The system is a transportable ultrasound system intended for use in environments where is provided by trained healthcare professionals.

The Clarius Ultrasound Scanner is a portable, general-purpose, software-controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through an off-the-shelf (OTS) iOS or Android device. The Clarius Ultrasound Scanner comprises a series of wireless transducers employing Bluetooth and Wi-Fi-based technology to communicate with traditional tablet/smartphone devices via direct Wi-Fi. This allows the user to export ultrasound images and display them across a range of portable personal devices. The system is a transportable ultrasound system intended for use in environments where is provided by trained healthcare professionals, including the emergency medical services (EMS) environment.

The Clarius Ultrasound Scanner is a software-based ultrasound imaging system and accessories, intended for diagnostic imaging. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: ophthalmic, fetal, abdominal, intra-operative (non-neurological), pediatric, small organ, cephalic (adult), trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), urology, gynecology, cardiac (adult, pediatric), peripheral vessel, carotid, and procedural guidance of needles into the body. The system is a transportable ultrasound system intended for use in environments where is provided by trained healthcare professionals.

The Clarius Ultrasound Scanner is a portable, general-purpose, software-controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through an off-the-shelf iOS or Android device. The Clarius Ultrasound Scanner comprises a series of wireless transducers employing Bluetooth and Wi-Fi-based technology to communicate with traditional tablet/smartphone devices via direct Wi-Fi. This allows the user to export ultrasound images and display them across a range of portable personal devices. Piezoelectric material in the systems transmits high frequency, non-ionizing sound waves to the designated region of the body and converts the subsequent echoes detected into electronic signals in order to construct an image of the internal structures of an anatomical field. This image is sent wirelessly to an external iOS or Android viewing device on which the image can be displayed. The transducer houses a battery and power generator, multichannel beam former, pre-scan converter, and Wi-Fi components. The battery is removable and comes with a separate charger. Communication between the transducer and the compatible viewing device is performed via Wi-Fi Direct® (Ad-Hoc mode with security) for easy pairing. The Clarius Ultrasound System product/package components include: 1. Software: . The Clarius Ultrasound App (Clarius App) for iOS; OR The Clarius Ultrasound App (Clarius App) for Android. ● 2. Transducers/Scanners: Clarius Scanner C3 (C3 Convex Transducer); . Clarius Scanner EC7 (EC7 Convex Endocavitary Transducer); Clarius Scanner C7 (C7 Convex Transducer); OR ● Clarius Scanner L7 (L7 Linear Transducer). 3. Accessories: a. Clarius-Built: o Battery Pack (Li-ion); Battery Charger; O Clarius Dock (Optional; charging station); and O Clarius Fan (Optional). O b. OEM/Off-the-Shelf Product(s): Medical Power Supply (Off-the-shelf power adaptor from SL Power Electronics; O Model Number ME20A1203B02; approved in the US); and Medical Power Supply (Optional for use with Clarius Dock; off-the-shelf power o adaptor from MEAN WELL Enterprises Co., Ltd.; Model Number GSM160B12-R7B; approved in the US). The concept of the Clarius Ultrasound System transducers and software is to provide an easy to use, highperformance, low-cost, ultrasound platform for teaching and clinical applications. The Clarius Ultrasound Scanner is intended for use in professional healthcare facilities where healthcare is provided by trained medical professionals. The device is also intended for use in Emergency Medical Service, ambulance, or rotary aircraft environments.

The Clarius Ultrasound Scanner is a software-based ultrasound imaging system and accessories, intended for diagnostic imaging in B-mode, M-mode, Color Doppler, Power Doppler, and Combined (B+M; B+Color Doppler; and B+Power Doppler). It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: ophthalmic, fetal, abdominal, intra-operative (non-neurological), pediatric, small organ, cephalic (adult), musculo-skeletal (conventional, superficial), urology, gynecology, cardiac (adult, pediatric), fetal echo, peripheral vessel, carotid, and procedural guidance of needles into the body. The system is a transportable ultrasound system intended for use in environments where is provided by trained healthcare professionals.

The Clarius Ultrasound System is a portable, general-purpose, software-controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through a commercial off the-shelf (COTS) iOS or Android device. The Clarius Ultrasound System comprises a series of wireless transducers employing Bluetooth and Wi-Fi-based technology to communicate with traditional tablet/smartphone devices via direct Wi-Fi. This allows the user to export ultrasound images and display them across a range of portable personal devices. Piezoelectric material in the systems transmits high frequency, non-ionizing sound waves to the designated region of the body and converts the subsequent echoes detected to electronic signals in order to construct an image of the internal structures of an anatomical field. This image is sent wirelessly to an external (COTS) iOS or Android viewing device on which the image can be displayed. The transducer houses a battery and power generator, multichannel beam former, pre-scan converter, and Wi-Fi components. The battery is removable and comes with a separate charger. Communication between the transducer and the compatible viewing device will be via Wi-Fi Direct® (Ad-Hoc mode with security) for easy pairing. The Clarius Ultrasound System product/package components include: 1. Software: The Ultrasound App (Clarius App) for iOS; OR The Ultrasound App (Clarius App) for Android. 2. Transducers/Scanners: Clarius C3 Scanner (C3 Convex Transducer); Clarius C3 Scanner (C3 Convex Transducer) with Clarius C3-L Clip-on; Clarius C7 Scanner (C7 Convex Transducer); OR Clarius L7 Scanner (L7 Linear Transducer). 3. Accessories: a. Clarius-Built: Battery Pack (Li-ion); and Battery Charger. b. OEM/Off-The-Shelf Product(s): Medical Power Supply (Off-the-shelf power adaptor from SL Power Electronics, USA; Model Number ME20A1203B02; Approved in the US); and Aquasonic 100 Ultrasound Transmission Gel (Off-the-shelf ultrasound gel from Parker Laboratories Inc., USA; Approved in the US). The concept of the Clarius Ultrasound System transducers and software is primarily to provide an easy to use, high-performance, low-cost, ultrasound platform for teaching and clinical applications. The Clarius Ultrasound System is intended for use in professional healthcare facilities where healthcare is provided by trained medical professionals. The device is also intended for use in Emergency Medical Service, ambulance, or rotary aircraft environments.