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Mobius3D software is used for quality assurance, treatment plan verification, and patient alignment and anatomy analysis in radiation therapy. It calculates radiation dose three dimensionally in a representation of a patient or a phantom. The calculation is based on read-in treatment plans that are initially calculated by a treatment planning system, and may additionally be based on external measurements of radiation fields from other sources such as linac delivery log data. Patient alignment and anatomy analysis is based on read-in treatment planning images (such as computed tomography) and read-in daily treatment images (such as registered cone beam computed tomography). Mobius3D is not a treatment planning system. It is to be used only by trained radiation oncology personnel as a quality assurance tool.

Mobius3D is a software product used within a radiation therapy clinic for quality assurance and treatment plan verification. It is important to note that while Mobius3D operates in the field of radiation therapy, it is neither a radiation delivery device (e.g. a linear accelerator), nor is it a Treatment Planning System (TPS). Mobius3D cannot design or transmit instructions to a delivery device, nor does it control any other medical device. Mobius3D is an analysis tool meant solely for quality assurance (QA) purposes when used by trained medical professionals. Being a software only QA tool, Mobius3D never comes into contact with patients.

The InThrill™ Thrombectomy System is indicated for: - The non-surgical removal of emboli and thrombi from blood vessels, including arteriovenous fistulae and arteriovenous grafts for dialysis access, and synthetic grafts. - Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel/graft. The InThrill™ Sheath is indicated for use as a conduit for the insertion of endovascular devices into the peripheral vasculature while minimizing blood loss associated with such insertions. The InThrill™ Thrombectomy System is intended for use in the peripheral vasculature. The InThrill™ Thrombectomy System is not intended for use in deep vein thrombosis (DVT) treatment.

The InThrill™ Thrombectomy System is a single-use, over-the-wire, catheter-based system for the minimally invasive treatment of thromboemboli in the peripheral vasculature, including arteriovenous fistulae and arteriovenous grafts for dialysis access, and synthetic grafts. The system comprises two main components packaged separately: - InThrill Sheath (8 Fr) - InThrill Thrombectomy Catheter (8 Fr) The InThrill Sheath is placed in the target vessel, and, after its funnel is expanded, the InThrill Catheter is inserted through the sheath and advanced past the thrombus. The InThrill Catheter coring element is deployed, providing wall-to-wall contact to engage the clot, and is then retracted into the InThrill Sheath to capture the targeted thrombus. Additional clot may be removed by aspiration through the sheath with a syringe (not provided). After the procedure is complete, the InThrill Catheter and InThrill Sheath are removed from the patient.

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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.

The Intracavitary/Interstitial System is intended for cancer treatment of the uterus, cervix, and vagina using HDR or PDR brachytherapy.

The Intracavitary/Interstitial System is a device with two (2), hollow, open-ended catheters which connect to applicator sets with ovoids, ring caps or templates on the distal end. The guide tubes extend outside of the patient. An interstitial needle is guided through the guide tube from outside the patient to an interstitial hole in the applicator. The proximal end of the guide tube contains a fixation mechanism for fixing the needle insertion depth between needle insertion and removal of the implant. The Intracavitary/Interstitial System is intended to be used with the following required accessories: Plastic Needles (K120341) and Leak Stop Channel Markers (K152018).

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.

The SpotLight / SpotLight Duo is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission projection data taken at different angles. The system has the capability to image cardiovascular and thoracic anatomies, including the heart, in a single rotation. The system may acquire data using Axial, Cine and Cardiac scan techniques from patients of all ages (DLIR is limited for patient use above the age of 2 years). These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories. This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes. The system is indicated for x-ray Computed Tomography imaging of cardiovascular and thoracic anatomies that fit in the scan field-of-view. The Low Dose CT Lung Cancer Screening Option for SpotLight / SpotLight Duo is indicated for using low dose CT for lung cancer screening. The screening must be conducted with the established program criteria and protocols that have been approved and published by a governmental body or a professional medical society. Information from professional societies related to lung cancer screening can be found but is not limited to: American College of Radiology® (ACR) – resources and technical specification; accreditation American Association of Physicists in Medicine (AAPM) – Lung Cancer Screening Protocols; radiation management. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information. The DLIR and ASIR-CV algorithms are not compatible with the Low Dose Lung Cancer Screening option. The device output is useful for diagnosis of disease or abnormality and for planning of therapy procedures.

The Low Dose Lung Cancer Screening (LD LCS) option indication for Arineta's SpotLight and SpotLight Duo scanners is being expanded to include small patients, as defined by AAPM (American Association of Physicists in Medicine). This expansion ensures comprehensive coverage of the intended lung cancer screening population, following the previous clearance of the LD LCS option for medium and large patients under K241200. The proposed LD LCS option for the SpotLight and SpotLight Duo includes scan protocols with CTDI that comply with AAPM's requirements for the whole LD LCS population patient size groups, as detailed in the following table: | Patient Size (AAPM group) | Weight (Kg) | CTDI (mGy) | SpotLight / SpotLight Duo - Indication for Use | |---|---|---|---| | Small | 50-70 Kg | 0.25-2.8 mGy | Proposed Device | | Medium | 70-90 Kg | 0.5-4.3 mGy | K241200 | | Large | 90-120 Kg | 1.0-5.6 mGy | K241200 | There are not any functional, performance, feature, or design changes required for the CT systems to which the option is applied. The proposed full LD LCS protocols option, as the cleared K241200, will be activated by service or production personnel, with no additional installation required (option activation only).

With radiotherapy equipment (Medical Linac, CT-Sim), it is used for patient positioning before treatment and continuous monitoring of patients during treatment, and can also be used to track patients' breathing mode (including DIBH, EEBH, 4DCT three breathing modes), in order to implement image acquisition synchronized with breathing and radiation therapy.

Klarity SGRT system offers a dedicated non-irradiating and non-invasive surface guided radiation therapy solution. SGRT system includes three main application modules: patient positioning, treatment (motion) monitoring and respiratory gating. With the patient positioning module, the SGRT system continuously senses the 3D patient body surface and compares it with the prerecorded reference surface by 3D image registration: The calculated 6 degree-of-freedom positioning deviations are visualized and sent to the positioning couch, to ensure a consistent and efficient inter-session patient setup/positioning, both manually and automated. With the treatment (motion) monitoring module, the SGRT system monitors the patient's surface in real-time throughout the treatment session. Once the body part surface exceeds the predefined tolerance, the system will automatically alert the therapist and turnoff the beam immediately. With the respiratory gating module, the system keeps tracking the patient's respiratory movements in real-time. During the treatment delivery, this functionality is used to maximize the protection of organs-at-risk; And in CT room, this functionality is used to make the 4DCT imaging best adapt to the patient's breathing in order to minimize the 4DCT imaging artifacts caused by the respiratory motion. Klarity SGRT system mainly consists of advanced software. PC workstation, one or three 3D cameras and calibration tools. SGRT system provides two models, ARSG-E1A and ARSG-E3A.

The FlowTriever2 Catheter is indicated for: • The non-surgical removal of emboli and thrombi from peripheral blood vessels. • Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The FlowTriever2 Catheter is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism (PE).

The Inari FlowTriever Retrieval/Aspiration System is a single-use, sterile medical device comprised of the following components, each packaged separately: • FlowTriever2 Catheter - Model 11-102 • Triever20® - Model 21-101 • Triever24® - Model 22-101 • Triever16® - Model 25-101 The FlowTriever2 Catheter is used to engage and retrieve emboli and thrombi. It consists of a coaxial catheter assembly with an outer Delivery Catheter and an inner catheter having a flexible shaft attached to distal self-expanding wireform element. A "Y" connector with a rotatable hemostatic valve and stopcock is attached to the proximal end of the outer Delivery Catheter. Radiopaque markers are positioned near the distal tip of the Delivery Catheter and at the proximal and distal ends of the self-expanding FlowTriever element to aid with fluoroscopic visualization. The Triever20 and Triever24 (packaged separately) provides a conduit for FlowTriever2 Catheter deployment, aspiration, and clot removal. It consists of a single lumen catheter with a proximal hemostasis valve and stopcock with flush port. A radiopaque marker is positioned near the distal tip to aid with fluoroscopic visualization. A Dilator compatible with a 0.035" guidewire is provided for the Triever20 and Triever24 to aid insertion. Alternatively, the Triever16 can be tracked through the Triever Catheter (20 or 24 Fr) over the pre-inserted guidewire to a location proximal to the targeted thrombus. Thrombus is removed via aspiration using the Triever16, after which it can be withdrawn and flushed to remove residual thrombus, leaving the Triever Catheter in place as a conduit for subsequent thrombectomy passes. The user may elect to perform a thrombectomy pass using the FlowTriever2 Catheter or through the Triever16 using aspiration alone. The Inari FlowTriever Retrieval/Aspiration System has not been evaluated for use in the neurovasculature.