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The EchoTech Easy3D is indicated for acquisition of related sets of 2D ultrasound images and 3D reconstruction of ultrasound images. It is intended to acquire, analyze, store, and retrieve digital ultrasound images for computerized 3D image processing. Easy3D is an add-on accessory to existing diagnostic ultrasound systems. Easy3D employs freehand scanning without the use of a coordinate and position sensor, therefore, the extension of the data set in the scanning direction is unknown. The images are not intended for use in diagnosis or quantitative measurements. The Easy3D is intended as a general purpose digital 3D ultrasound image processing tool for use in obstetrics for qualitative evaluation of deformities and determination of the need for further fetal ultrasound studies. The EchoTech 3D FreeScan system is indicated for acquisition of related sets of 2D ultrasound images and 3D reconstruction of ultrasound images. It is intended to acquire, and retrieve digital ultrasound images for computerized 3D image processing. Easy3D is an add-on accessory to existing diagnostic ultrasound systems. Easy3D employs freehand scanning with the use of a coordinate and position sensor and, optionally, with heart cycle (R-Peak) triggering, which enables cardiovascular imaging. The EchoTech EasyArchive system is indicated to acquire, digitize, archive, and retrieve single or sequences of 2D ultrasound images. EasyArchive is an add-on accessory to existing diagnostic ultrasound systems. EasyArchive is intended as a general purpose digital ultrasound image processing and archiving tool for use in radiology, neurology, gastroenterology, surgery, orthopedics, cardiology, oncology, obstetrics and gynecology. The EchoTech Quanticon system is indicated in the acquisition of either heart cycle (R-Peak) triggered or nontriggered sequences of 2D ultrasound images for use in the evaluation of contrast agent-based ultrasound exams. In the sequence of images multiple Regions Of Interest (ROI) can be selected. Inside these chosen regions the average gray value or the number of color pixels is calculated over time. Quanticon is intended an add-on accessory to existing diagnostic ultrasound systems. Quanticon is intended as a general digital ultrasound processing and archiving tool for use in cardiology, radiology, and neurology, The EchoTech EasyStress system is indicated for the acquisition of heart cycle (R-Peak) triggered sequences of 2D ultrasound images for use in performing, scoring, measuring, and archiving stress echo studies. The EasyStress system utilizes the ASE Standard for Wall Motion Scoring to quantify wall motion abnormalities of the heart. EasyStress is an add-on accessory to existing diagnostic ultrasound systems. EasyStress is a digital ultrasound image processing and archiving tool for use in cardiology.

The following products produced by Echotech 3D Imaging Systems are included in this 510(k) premarket notification: - Easy3D Family . - 3D FreeScan . - EasyArchive . - Quanticon . - EasyStress . All of the subject products are accessories to diagnostic ultrasound imaging systems. The products are high performance computer systems based on Intel motherboard and WindowsNT standards. The systems incorporate commercially available image digitizer circuit boards for acquisition, storage, annotation, reporting, and retrieval of ultrasound image data. They also incorporate proprietary image processing software developed by EchoTech 3D Imaging Systems. The EchoTech Easy3D Family system is a high performance computer system based on Intel motherboard and WindowsNT standards. It incorporates a commercially availabel image digitizer circuit board for acquisition, storage and retrieval of ultrasound image data. The device is an add-on accessory for any existing diagnostic imaging ultrasound system. The system acquires either heart cycle (R-Peak) triggered or nontriggered sequences of 2D ulrasound images (B/W and Color) The 2D ulrasound images are acquired through video output port of the host ultrasound system as the ultrasound transducer is moved across the patient scan site. The resulting set of digitized 2D images is then converted into a 3D data volume under the assumption that a predefined scan movement was followed. In this step redundant gray values are eleminated, gaps are filled by a trilinear interpolation and the images are sorted depending on the time delay to the R-Peak. The acquisition process might be R-Peak triggered by the heart cycle. This is done by importing an Audio or TTL signal from the Physio module of the ultrasound system. The EchoTech 3D FreeScan system is a high performance computer system based on Intel motherboard and WindowsNT standards. It incorporates a commercially availabel image digitizer circuit board for the acquisition, storage and retrieval of digital dynamic 3D ultrasound image data sets. The device is an add-on accessory for any existing diagnostic imaging ultrasound system. The device records ultrasound transducer spatial position in six degrees of freedom during use. Coordinate tracking is achieved with a miniature magnetic field sensor within a transmitted pulsed magnetic field. This is done by attaching a plastic holding plate to the probe of the host ultrasound system, to which the receiver of an electromagnetic sensor device is attached. 2D ulrasound images are acquired triggerd sequentially in a series of steps as the ultrasound transducer is moved across the patient scan site. The resulting set of digitized 2D images is then converted into a 3D data volume. The acquisition process is R-Peak triggered by the heart cycle. This is done by importing an Audio or TTL signal from the Phvsio module of the ultrasound system. The commercially available coordinate sensor device consists of an IBM compatible PC board, a tranmitter and a receiver. The transmitter generates a spherical magnetic field and the receiver can be moved anywhere within 1m of the transmitter to generate a set of 3 translational and 3 angulation values. The 3D FreeScan system digitizes R-Peak triggerd the ulrasound images from the video output port of the host ultrasound system through a video cable. The images are stored in the computer memory. In a postprocessing step the oblique images are transformed into a Cartesian coordinate system. In this step redundant gray values are eleminated, gaps are filled by a trilinear interpolation and the images are sorted depending on the time delay to the R-Peak. The EchoTech EasyArchive system is a high performance computer system based on Intel motherboard and WindowsNT standards. It incorporates a commercially availabel image digitizer circuit board for acquisition, storage and retrieval of ultrasound image data. The device is an add-on accessory for any existing diagnostic imaging ultrasound system. The system acquires single 2D ultrasound images or sequences of 2D ulrasound images. The EasyArchive system digitizes the ulrasound images from the video output port of the host ultrasound system through a video cable. The images or sequneces are stored in the computer memory. The data can be stored along with patient adminstrative data in a data base on the EasyArchive harddisk or on removeable media for later display and retrieval. The EchoTech QuantiCon system is a high performance computer system based on Intel motherboard and WindowsNT standards. It incorporates a commercially availabel image digitizer circuit board for acquisition, storage and retrieval of ultrasound image data. The device is an add-on accessory for any existing diagnostic imaging ultrasound svstem. The system acquires either heart cycle (R-Peak) triggered or nontriggered sequences of 2D ulrasound images. In the sequence of images multiple Regions Of Interest (ROI) can be selected. Inside these regions the average gray value or the number of color pixel is calculated over time. The QuantiCon system digitizes the ulrasound images from the video output port of the host ultrasound system through a video cable. The trigger signal for the acquisition process is taken from the ultrasound system either as an Audio beep or as a TTL signal. The images are stored in the computer memory. In a postprocessing step the images are lossless compressed (runlength compression). The postprocessed data can be stored along with patient adminstrative data in a data base on the QuantiCon harddisk or on removeable media for later display and retrieval. The EchoTech EasyStress system is a high performance computer system based on Intel motherboard and WindowsNT standards. It incorporates a commercially availabel image digitizer circuit board for acquisition, storage and retrieval of ultrasound image data. The device is an add-on accessory for any existing diagnostic imaging ultrasound system. The system acquires heart cycle (R-Peak) triggered sequences of 2D ulrasound images. Corressponding to the guidelines of the American Society of Echocardiographie ASE 16 sequences can be acquired. (4 stress phases and for each stress phase four standard views of the heart). The sequences can be synchronized replayed either sorted after stress phase or standard views. In the replay mode wall mation scoring WMS can be carried out following the guidelines of the ASE. The EasyStress system digitizes the ulrasound images from the video output port of the host ultrasound system through a video cable. The trigger signal for the acquisition process is taken from the ultrasound system either as an Audio beep or as a TTL signal. The images are stored in the computer memory. In a postprocessing step the images are lossless compressed (runlength compression). The postprocessed data can be stored along with patient adminstrative data in a data base on the EasyStress harddisk or on removeable media for later display and retrieval.