Devices

Device Recall Radiation Therapy Treatment Planning System

Model / Serial
Software version and build numbers are 2.5.0.144 and 2.5.1.89. Product lifetime is 5 years.
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution: USA (nationwide) including states of: FL, MA, NJ, and NY; and countries of: Canada Germany, Netherlands and Switzerland.
Product Description
Brand name: RayStation. Generic name: Treatment Planning System. Software version and build numbers are 2.5.0.144 and 2.5.1.89. Product lifetime is 5 years. || 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. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.
Manufacturer
RAYSEARCH LABORATORIES AB
1 Event
- Recall of Device Recall Radiation Therapy Treatment Planning System

Manufacturer

RAYSEARCH LABORATORIES AB

Manufacturer Address
RAYSEARCH LABORATORIES AB, Sveavaegen 9, Stockholm Sweden
Manufacturer Parent Company (2017)
Raysearch Laboratories Ab (Publ)
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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