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ScanNav Anatomy Peripheral Nerve Block is indicated to assist qualified healthcare professionals to identify and label the below mentioned anatomy in live ultrasound images in preparation for ultrasound guided regional anesthesia prior to needle insertion for patients 18 years of age or older. The highlighting of structures in the following anatomical regions is supported: - · Axillary level brachial plexus - · Erector spinae plane - · Interscalene level brachial plexus - · Popliteal level sciatic nerve - · Rectus sheath plane - · Sub-sartorial femoral triangle / Adductor canal - · Superior trunk of brachial plexus - · Supraclavicular level brachial plexus - · Longitudinal suprainguinal fascia iliaca plane - Femoral block ScanNav Anatomy Peripheral Nerve Block is an accessory to compatible general-purpose diagnostic ultrasound systems.

ScanNav Anatomy Peripheral Nerve Block is a software (SaMD) which assists qualified healthcare professionals to identify and label relevant anatomical structures in preparation for ultrasound guided regional anesthesia prior to needle insertion for patients 18 years of age or older. The device receives ultrasound images in real-time from a compatible general-purpose ultrasound machine. It processes these images using deep learning artificial intelligence algorithms and highlights relevant anatomical structures. The ultrasound machine display remains unaffected, and the highlighting is only displayed on a general-purpose panel PC provided with the device.

ScanNav Anatomy Peripheral Nerve Block is indicated to assist qualified healthcare professionals to identify and label the below mentioned anatomy in live ultrasound images in preparation for ultrasound guided regional anesthesia prior to needle insertion for patients 18 years of age or older. The highlighting of structures in the following anatomical regions is supported: - Axillary level brachial plexus ● - Erector spinae plane . - Interscalene level brachial plexus ● - Popliteal level sciatic nerve . - Rectus sheath plane - Sub-sartorial femoral triangle / Adductor canal . - Superior trunk of brachial plexus - Supraclavicular level brachial plexus ● - . Longitudinal suprainguinal fascia iliaca plane ScanNav Anatomy Peripheral Nerve Block is an accessory to compatible general-purpose diagnostic ultrasound systems.

ScanNav Anatomy Peripheral Nerve Block is a software medical device which assists anesthetists and other qualified healthcare professionals in the identification of anatomical structures within ultrasound images during ultrasound-guided regional anesthesia (UGRA) procedures by highlighting the relevant anatomical structures in realtime. The device performs the highlighting by using deep learning artificial intelligence technology based on convolutional networks (CNNs). These deep-learning models generate a colored overlay that allows the user to identify the specific anatomical structures of interest for the procedure. A separate monitor displays the highlighted images as an overlay on top of the ultrasound image, so the original view from the ultrasound machine is not affected. The deep learning models are locked, and they do not continue to learn in the field. The device interfaces with ultrasound machine with an external monitor output that meets the compatibility requirements. The ScanNav Anatomy Peripheral Nerve Block is run on a mobile computing platform (a commercial off the shelf panel PC) performing the processing with an integrated touchscreen monitor to display the user interface and anatomy highlighting The Software as a Medical Device is packaged with a tablet PC, power cable, compatible plug, and mounting bracket and instructions for mounting the tablet to the ultrasound host. This acts as a separate monitor to display the highlighted images as an overlay on top of the ultrasound image, so the original view from the ultrasound machine is not affected. The ScanNav Anatomy Peripheral Nerve Block system is composed of a software medical device and other non-medical devices such as a panel PC, power supply, an HDMI interface cable and a VESA mount.