U.S. FDA — Device Enforcement · United States · 2023-02-28 · Class II
As described by U.S. FDA — Device Enforcement: Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
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Nationwide distribution in the US. International distribution to Albania, Algeria, Antigua and Barbuda, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegowina, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cuba, Curacao, Cyprus,
Reported risk: Re-optimization, after adding contours without forced density outside the external structure, may result in inaccurate dose presentation.
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