FDA-Device2025-05-28Class II
True 3D Viewer, Model: EP-00003
Echopixel, Inc.
Hazard
With certain software versions, import of enhanced ultrasound formatted data/ultrasound images into 3D viewer, (for digital image processing/review/analysis/communication/media interchange acquired from CT/MRI/ultrasound, and pre-operative analysis of surgical options), can result in incorrect display of image orientation, which could result in misdiagnosis or incorrect surgical treatment plan.
Sold states
Worldwide - US Nationwide distribution in the states of CA, OH, NJ, PA, MA, FL, CT, TX, LA, MI, MN and the country of CA.
Affected count
18
Manufactured in
780 Montague Expy Ste 305, N/A, San Jose, CA, United States
Products
True 3D Viewer, Model: EP-00003
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1785-2025Don't want to check this manually?
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