FDA-Device2025-02-19Class II
MOSAIQ Oncology Information System
Elekta, Inc.
Hazard
Image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale.
Sold states
US: PA, AL, FL, IA UT OUS: Austria Belgium Bolivia Bosnia and Herzegowina Brazil Canada France Germany Hong Kong Italy Japan Korea, Republic of Malta Netherlands Panama South Africa Spain Taiwan Thailand Turkey Venezuela
Affected count
64 units
Manufactured in
400 Perimeter Center Ter NE Ste 50, Atlanta, GA, United States
Products
MOSAIQ Oncology Information System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1162-2025Don't want to check this manually?
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