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.

Imaging system data may be displayed with an incorrect orientation (sidedness) where the patient side is not correct (left, right, superior, inferior, anterior or posterior). This may lead to an inaccurate measurements.

On 03/25/2026, the firm sent via email and telephone an Urgent Field Safety Notice, informing customers of a potential misdiagnosis or incorrect surgical treatment planning approach can result when utilizing Enhanced Multi-frame DICOM image data sets. Customers were instructed to: verify if Enhanced Multi-Frame CT DICOM files have been used with the software. If users have utilized this file type, we request that users verify retrospectively any potential risk to health of patients and further determine if this patient needs to be reevaluated and report it to EchoPixel, Inc. We request that the True 3D Viewer versions 1.0, 1.25, 1.35 NOT be used with this file type. For any questions or concerns - contact EchoPixel, Inc Monday thru Friday 9 AM - 6 PM Pacific at: Mailing address: 2490 Hospital Dr. Suite 310, Mountain View CA 94040 Email: [email protected] Phone: +1 (844) 273-7766