FDA-Device2020-05-06Class II
Elekta MONACO RTP Sytem, radiation treatment planning software system - Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The
Elekta Inc
Hazard
The Monaco RTP Radiation Treatment Planning System may change the shape and volume of the contour potentially resulting in the device delivering an inaccurate dose.
Sold states
Worldwide distribution - US Nationwide Distribution in the states of IA, NJ, NY, PA, TX, WI and the countries of Australia, Canada, China, Denmark, Germany, Hong Kong, Italy, Netherlands, Sweden, Switzerland, Thailand, Turkey, United Kingdom.
Affected count
96 devices
Manufactured in
1450 Beale St Ste 205, N/A, Saint Charles, MO, United States
Products
Elekta MONACO RTP Sytem, radiation treatment planning software system - Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1825-2020Don't want to check this manually?
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