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The iView™ is intended to be used by or under the direction of qualified medical personnel during prenatal monitoring, to visualize fetal features in a reconstructed 3D image that they may wish to exam more closely during routine 2D fetal diagnostic ultrasound imaging examinations, and to assist patient's understanding in communicating diagnostic results in a form that may be more easily understood. It does not provide quantitative measurements or diagnostic interpretations. The subject device may only be used in an adjunctive capacity with standard diagnostic ultrasound imaging techniques and that no clinical decisions or diagnostic interpretations should be made based solely on the use of this device. 3D image reconstructed from this software is referring use only and is not responsible for any diagnosis.

Adds 3D imaging capability to commercial 2D ultrasound imaging systems