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Echo-View™ 4.X is intended to retrieve, analyze and store digital ultrasound images for computerized 3-dimensional and 4-dimensional (dynamic 3D) image processing. Echo-View™ 4.x can import certain digital 2D or 3D image file formats for 3D tomographic reconstructions and surface rendering. It is intended as a general purpose digital 3D ultrasound image processing tool for cardiology, radiology, neurology, gastroenterology, urology, surgery, obstetrics and gynecology.

The Echo-Viewis a software module for high performance computer systems based on Microsoft Windows NT™ 4.0 operating system standards. Echo-Viewis proprietary software for the analysis, storage, retrieval and reconstruction of digitized ultrasound B-mode images and Color Doppler images.

The data can be acquired by a TomTec acquisition station or by a 3D capable ultrasound system. The result of acquired images allows a 3-dimensional volume to be reconstructed by Echo-View. The digital 3D / 4D data set can be used for 2D and 3D measurements.

This document is a 510(k) summary for the TomTec EchoView 4.x, Easy-View 1.x, and Omni-View 1.x digital ultrasound image analysis systems. It details the device description, classification, and substantial equivalence to a predicate device (TomTec Echo-View K934139). However, it is a premarket notification and does not contain information about acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested information from the given text. The document is for regulatory clearance and focuses on device description and substantial equivalence, not performance study results or acceptance criteria.

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