FDA-Device2025-12-24Class II
Intelerad InteleShare software, with ProViewer component
DICOM Grid, Inc.
Hazard
Software intended to aid in diagnosing conditions, planning treatments, visualizing anatomical structures has a bug that, if all of following are met: Viewing images in InteleShare viewer; Multiplanar reconstruction applied; Manual rotation applied, could result in inaccurate length measurement tool values that could compromise diagnostic accuracy, lead to misdiagnosis or inappropriate follow-up.
Sold states
US: AZ, TX, GA, NV, MO, MI, IL, OH, CT, OR, FL, NY, NM, MN, PA, AK, ND, NJ, VA, WA, NC, TN, WI, GA, AK, CA, SD, CO, MA, WV, MN, KS, MD, VT, IA, RI, AL, ID, LA, PR, NH, IN, OK, UT, NE, SC, AR, DE OUS: CA, NZ, AU, GB, BE, FR, IT, NO, SE
Affected count
924
Manufactured in
305 Church At North Hills St, Raleigh, NC, United States
Products
Intelerad InteleShare software, with ProViewer component
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0941-2026Don't want to check this manually?
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