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Sources: EU EUDAMED, US FDA
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RayStation 6, UDI # 07350002010013 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
FDA Enforcement
Class II
·Terminated·RAYSEARCH LABORATORIES AB·June 17, 2020
RayStation 8A, UDI # 07350002010112 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
FDA Enforcement
Class II
·Terminated·RAYSEARCH LABORATORIES AB·June 17, 2020
RayStation 9B, UDI # 07350002010266 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
FDA Enforcement
Class II
·Terminated·RAYSEARCH LABORATORIES AB·June 17, 2020
RayStation 9A, UDI # 07350002010174 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
FDA Enforcement
Class II
·Terminated·RAYSEARCH LABORATORIES AB·June 17, 2020
RayStation 8B, UDI # 07350002010129 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
FDA Enforcement
Class II
·Terminated·RAYSEARCH LABORATORIES AB·June 17, 2020
RayStation 7, UDI # 07350002010068 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
FDA Enforcement
Class II
·Terminated·RAYSEARCH LABORATORIES AB·June 17, 2020
RayStation 6 Service Pack 2, UDI # 07350002010075 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
FDA Enforcement
Class II
·Terminated·RAYSEARCH LABORATORIES AB·June 17, 2020
RayStation 6 Service Pack 3, UDI # 07350002010242 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
FDA Enforcement
Class II
·Terminated·RAYSEARCH LABORATORIES AB·June 17, 2020
RayStation 9B Service Pack 1, UDI # 07350002010297 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
FDA Enforcement
Class II
·Terminated·RAYSEARCH LABORATORIES AB·June 17, 2020
RayStation 8B Service Pack 1, UDI # 07350002010204 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
FDA Enforcement
Class II
·Terminated·RAYSEARCH LABORATORIES AB·June 17, 2020
RayStation 8B Service Pack 2, UDI # 07350002010235 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
FDA Enforcement
Class II
·Terminated·RAYSEARCH LABORATORIES AB·June 17, 2020
RayStation 5 Service Pack 3, UDI # 07350002010020 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
FDA Enforcement
Class II
·Terminated·RAYSEARCH LABORATORIES AB·June 17, 2020
RayStation 8A Service Pack 1, UDI # 07350002010136 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
FDA Enforcement
Class II
·Terminated·RAYSEARCH LABORATORIES AB·June 17, 2020
RayStation 4.0 to RayStation 5 Service Pack 2 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
FDA Enforcement
Class II
·Terminated·RAYSEARCH LABORATORIES AB·June 17, 2020
RayStation 6 Service Pack 1, UDI #s 07350002010037, 07350002010082 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
FDA Enforcement
Class II
·Terminated·RAYSEARCH LABORATORIES AB·June 17, 2020
Permobil powered wheelchairs, Model Numbers: (a) M300 PS, (b) C300 PS, (c) C350 PS, (d) C500 PS, (e) C400 PS Product Usage: The devices identified are intended to provide outdoor and indoor mobility to persons limited to a seated position that can operate a powered wheelchair.
FDA Enforcement
Class II
·Terminated·Permobil, Ab·September 26, 2018
Etac Supporter toilet armrest Etac Supporter toilet armrests are foldable and have comfortable rounded grips for the hands. Supporter is simple to mount without the need for any tools. It fits both floor and wall mounted toilets. If space around the toilet is limited either armrest can easily be detached. Supporter includes seat ring and lid.
FDA Enforcement
Class II
·Terminated·Etac Supply Center Ab·July 22, 2015
Etac Relax wall mounted shower seat The Etac Relax is a wall mounted shower seat designed as a seating and standing support for personal hygiene purposes for people with reduced mobility. The Etac Relax shower seat is used for sitting where space is restricted, and can be folded up when not in use. Etac Relax is intended for home use.
FDA Enforcement
Class II
·Terminated·Etac Supply Center Ab·August 19, 2015
Radiation Therapy Treatment Planning System, Model 4.5, 4.7, 5.0 RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs
FDA Enforcement
Class II
·Terminated·RAYSEARCH LABORATORIES AB·April 19, 2017
RayStation standalone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 7.0, 8.0, 8.1, 9.0, 9.1 - Product Usage: RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. After a proposed treatment plan is reviewed and approved by authorized intended users, RayStation may also be used to administer treatments. The system functionality can be configured based on user needs.
FDA Enforcement
Class II
·Ongoing·RAYSEARCH LABORATORIES AB·April 1, 2020