Proteus PLUS

Serial Number: SAT.123 (US), and SBF.101 (EU). Versions PTS-9.3.1.2 and PTS-9.4.0

Radiology Devices

2

No

Distribution in US (to Louisiana), and France.

Proteus 235, Proton Therapy System

Serial Numbers: PAT.000,PAT.003, PAT.006, PAT.107, PAT.108, PAT.109, PAT.111, PAT.112, PAT.113, PAT.114, SAT.115, SAT.116, SAT.117, SAT.119, SAT.120, SAT.122, SAT.123, SAT.126

Radiology Devices

2

No

Worldwide Distribution - US Distribution to the states of : MA, FL, VA, PA, IL, NJ, WA, TN, LA and TX., and to the countries of: Germany, South Korea, France, Czech Republic, Italy, Poland and Sweden.

Proteus 235

Serial numbers: PAT.003, PAT.006

Radiology Devices

2

No

FL

Proton therapy system -Proteus 235 aka Proteus Plus. || A medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.

PAT.003 and PAT.006

Radiology Devices

2

No

Units were distributed to Korea and Jacksonville, FL.

The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) || Proteus 235, Beam Management System (PBS)

Code/Serial Numbers: PAT.000, PAT.003, PAT.006, PAT.107, PAT.108, PAT.109, PAT.110, PAT.111, PAT.112, PAT.113, PAT.114, PAT.115, SAT.116, SAT.117, SAT.119, SAT.120, SAT.122, SAT.123, SAT.126.

Radiology Devices

2

No

Units were distributed in the USA, Korea, Germany, France, Czech Republic, Italy, Poland, and Sweden. Each country's national Competent Authorities have been informed.

Proteus 235 || The PTS is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.