(28 days)
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.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.