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The ImaCor Zura Handheld ZHH-010 is a software-based handheld ultrasound imaging system and accessories, intended for diagnostic imaging. It is indicated for diagnostic ultrasound imaging using the ImaCor ClariTEE probe. (Cardiac, TEE) The system is intended for use in critical care environments where healthcare is provided by trained healthcare professionals. It is not for pediatric use (Less than 18 years of age) It is not for use in EMS settings.

The ImaCor Zura Handheld ZHH-010 is a portable, cardiac, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through a commercial offthe-shelf (COTS) Android™ device. The scanner is Bluetooth and Wi-Fi- based, communicating with a traditional tablet/smartphone via direct Wi-Fi to allow users to export ultrasound images and display in different modes of operation. The ImaCor Zura Handheld ZHH-010 houses a battery and internal power supplies, multichannel beamformer, pre-scan converter and Wi-Fi components. The battery is removable and comes with a separate charger. The system is a transportable (handheld) ultrasound system intended for use in environments where healthcare is provided by trained healthcare professionals. The ImaCor Zura Handheld ZHH-010 is not to be used in a fixed- or rotary-winged air ambulance. Piezoelectric material in the system's transducer (ClariTEE probe) transmits high frequency, non-ionizing sound waves to the designated cardiac region of the body and converts the subsequent echoes detected into electronic signals to construct an image of the internal structures of an anatomical field. This image is sent wirelessly to an external Android viewing device on which the image can be displayed. Communication between the scanner and the compatible viewing device is performed via Wi-Fi Direct® (Ad-Hoc mode with security) for easy pairing. The ImaCor Zura Handheld ZHH-010 product components include: 1. Software: SOUP Imaging App for Android 2. Transducers/Scanners: ImaCor ClariTEE probe (TEE probe); 3. Accessories: ImaCor Battery (Li-ion); ImaCor Battery Charger; ImaCor Fan; Medical Power Supply (off-the-shelf power adaptor from GlobTek, Inc.; Model Number WR9QA3200USBNMEDR6B; approved in the US).

1. The Zura-EVO System is intended for the following applications: Cardiac and , Transesophageal. Measurement and calculation packages that provide information of anatomical structures that may be used by a physician for clinical diagnosis purposes. 2. When used with the ClariTEE probe -- The episodic assessment of cardiac function using transesophageal echocardiography (TEE). It is indical for use in clinical settings including long term settings such as the ICU for an indwelling time not to exceed 72 hrs. 3. When used with the TTE probe is intended for imaging and assessment of Cardiac anatomy and function

The Zura-EVO Imaging System is a multi-purpose mobile, software controlled diagnostic ultrasound system. Its function is to acquire ultrasound echo data and display it in B-Mode, or Color Doppler Mode on a Flat Panel Display. The user interface includes specialized controls, a minimized computer keyboard, and touch panel on an ergonomic console. The system has an optional electrocardiography (ECG) display feature and support for a 3- lead ECG cable assembly. The systems provide measurement capabilities for anatomical structures that provide information used for clinical diagnostic purposes. The system has measurements and calculations, image storage and review, and recording capabilities. The systems include a Digital Imaging and Communications (DICOM) module which enables storage. The Zura-EVO Imaging System consists of the following major components: 1. Ultrasound Machine: A predicate device ultrasound machine (K102997) 2. Ultrasound Probes a. ClariTEE Probe: A miniaturized TEE probe optimized for longer dwell time relative to standard TEE probes that enables long term use in clinical settings such as the ICU. This probe has predicate coverage under K080223 and K100969. b. TTE probe SA4-2/24: Transthoracic probe has a predicate coverage under K102997 3. Ultrasound Imaging Software: Ultrasound imaging functions are controlled via the ImaCor Zura software. The Graphical User Interface, which is the piece of software exposed to the user, communicates user inputs to the Ultrasound Imaging Platform which interfaces with the Ultrasound Transducer. The ImaCor Zura software also communicates with the probe directly to monitor the probe's lifespan. Orientation and position of the probe is controlled manually by the user.

The ImaCor Zura system with ClariTEE probe is intended for use in the episodic assessment of cardiac function using transesophageal echocardiography. It is indicated for use in clinical settings, including long term settings such as the ICU. for an indwelling time period not to exceed 72 hours. The ImaCor Zura system with ClariTEE probe is not intended for pediatric use

The ImaCor Zura system with ClariTEE probe consists of three main components: 1. Ultrasound Machine: A TEE predicate device optimized for use with ImaCor ClariTEE probe. 2. Ultrasound Probe (ClariTEE formerly known as the Blue Probe in K080223): A miniaturized TEE probe optimized for longer dwell time relative to standard TEE probes enables use in longer term clinical settings such as the ICU. The probe distal tip is flexed upward transiently to obtain standard TEE images. 3. Ultrasound Imaging Software: The software controls standard ultrasound machine functions such as imaging, recording and measuring. Continuous imaging is limited by a 20 minute software interlock should the operator mistakenly leave the machine in continuous imaging mode, thus limiting the potential unintentional exposure of the patient's mucosal tissue to acoustic energy. Maximum probe face temperature is limited according to FDA consensus standard IEC 60601-2-37. Latest software version enables two modes of operation; type B and color flow Doppler. The subsequent version cleared for marketing under K080223 enabled type B only.