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510(k) Data Aggregation
K Number
K142107Device Name
ECHO TRUE 3D VIEWER
Manufacturer
ECHO PIXEL INC.
Date Cleared
2015-01-21
(173 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
ECHO PIXEL INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended as a medical diagnostic imaging system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from CT or MR imaging devices. It is also intended as preoperative software for simulating surgical treatment options. The True 3D Viewer is designed for use by health care professionals and is intended to assist the clinician who is responsible for making all final patient management decisions.
Device Description
The True 3D 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. The t3D-Viewer software application loads DICOM image data and presents a stereoscopic 3D rendered view of the DICOM image data. The t3D-Viewer software application enables HCPs to visualize and interact with image data and depictions of tissue and organs as if they were real physical objects.
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