Echopixel, Inc.
Echopixel, Inc. holds FDA 510(k) medical device clearances, first cleared 2015, most recent 2020, with 2 FDA device recalls on record.
Top product codes for Echopixel, Inc.
FDA recalls by Echopixel, Inc.
- Z-1785-2025 — True 3D Viewer, Model: EP-00003
- Z-1807-2025 — 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.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Echopixel, Inc.
Data sourced from openFDA. This site is unofficial and independent of the FDA.