2 results
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX Software versions 1.0, 1.25, and 1.35 The t3D-Viewer is designed for use by health care professionals HCPs and is intended to assist the clinician who is responsible for making all patient management decisions. The True 3D Viewer (t3D-Viewer) system is comprised of a commercial off the shelf hardware platform and a proprietary software application that enables a health care professional (HCP) to visualize and interact with CT and MRI DICOM image data to assist in clinical decision making. The t3D-Viewer system hardware platform is comprised of an off the shelf stereoscopic display, an optical or electromagnetic motion tracking system and a computer system.
FDA Enforcement
Class II
·Ongoing·Echopixel, Inc.·May 28, 2025
True 3D Viewer, Model: EP-00003
FDA Enforcement
Class II
·Ongoing·Echopixel, Inc.·May 28, 2025