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MDxNet is intended for use under physician's orders and/or oversight and management. MDxNet is indicated for acquisition of related sets of 2D ultrasound images and 3D reconstruction of ultrasound images in the adult and pediatric patient utilizing existing ultrasound systems. It is intended to acquire, analyze, store and retrieve digital ultrasound images for computerized 2D and 3D image processing. MDxNet is indicated to acquire, digitize, archive and retrieve single or sequences of 2D ultrasound images. MDxNet is intended as a general purpose digital image processing and archiving tool for use in abdominal, pelvic, fetal, cardiac, peripheral vascular and neurovascular imaging. MDxNet add-on indications are for the assessment of pulmonary function to acquire, analyze, store and retrieve this assessment in male/female adult and pediatric patients utilizing FDA approved Spirometry. MDxNet additional add-on will provide 12-lead resting electrocardiogram (ECG) which permits the detection of abnormalities in the transmission of the cardiac impulse through the heart muscle and serves as an important aid in the diagnosis of heart ailments through utilizing 12-lead ECG.

MDxNet consists of MDxPAC, MDxStation (PC or Notebook, laptop computer), MDxServer, and the proprietary software component called MDxView. MDxPAC consists of limited hardware, that bundle and power FDA approved Commercial Off-The-Shelf devices (COTS). MDxNet features an integrated 2D/3D streaming engine which permits PC's or notebooks to control the server and to review 2D and 3D reconstructions. MDxNet is capable of image review, archiving, data collection, database maintenance, reporting and basic 3D capabilities including color rendering. Upon receipt of FDA approval to market MDxNet, finished devices will be distributed only under direction and/or orders of physicians. MDxNct inherits and integrates concepts first pioneered in the National Aeronautics and Space Administration (NASA) sponsored Telemedicine Instrument Pack (TIP) project and the Defense Advanced Research Projects Agency (DARPA) sponsored Medical Ultrasound Three-dimensional, Portable with Advanced Communication (MUSTPAC) project, and its predecessors. It expands capability to include a server component, augments data acquisition to include wireless options, redesigns the Graphical User Interface (GUI) for more intuitive interaction and provides improved packaging for better usability. MDxNet has the capability to record 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 FDA approved probe of the host Ultrasound system, to which the receiver of an electromagnetic sensor device is attached. 2D ultrasound images are acquired 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. IQmark Digital ECG and Spirometer both FDA approved devices have been integrated into MDxNet as requested by the end user of the validation study. The Midmark software for each of these devices and indications of use have not been altered, though permit the end user as demonstrated in both clinical studies to capture additional potentially key clinical results within MDxNet for data collection, review, comparison, reporting and archiving.