đź“‹ FDA Reference
Syngo Dosimetrist Workspace V2 7 Model 1056864
Siemens Medical Solutions U
Summary: The syngo dosimetrist workspace v2 7 is a medical device used in the planning and management of radiation therapy. It is primarily utilized by radiation oncologists and dosimetrists to optimize treatment plans for patients undergoing radiation therapy.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K101119 ↗
Decision Date ?
June 16, 2010
Product Code ?
MUJ
Device Class ?
Class 2
Evidence ?
0 studies
The syngo dosimetrist workspace v2 7, manufactured by Siemens Medical Solutions U, was cleared through the FDA 510(k) pathway on June 16, 2010. It is classified as a Class 2 device under product code MUJ.
What It Is
The syngo dosimetrist workspace v2 7 is a software platform designed to assist in the planning and administration of radiation therapy. It provides tools for dosimetrists to calculate and optimize radiation doses, ensuring precise targeting of tumors while minimizing exposure to surrounding healthy tissues. This device integrates with other imaging and treatment systems to streamline the workflow in radiation oncology departments.
FDA-Cleared Indications
- For use in the planning of radiation therapy treatments.
- For use by qualified radiation oncology professionals to develop and evaluate radiation treatment plans.
- The FDA record identifies the device under product code MUJ as a Class II radiation therapy treatment planning system.
Clinical Applications
- Planning external-beam radiation therapy for patients with cancer.
- Calculating and evaluating radiation dose distributions.
- Optimizing treatment plans to target tumors while limiting dose to nearby normal tissue.
- Supporting treatment planning workflows for complex radiation therapy techniques when configured and validated for those techniques.
- Reviewing treatment plan information before clinical delivery according to institutional quality-assurance procedures.
Practical Considerations
- This is software rather than an implantable or patient-contact device; it has no physical device size or vessel access requirements.
- Compatibility with imaging systems, treatment-planning components, oncology information systems, and radiation treatment machines should be confirmed before installation.
- Use requires trained radiation oncologists, medical physicists, and dosimetrists, with independent treatment-plan review and quality assurance.
- The software does not replace clinical judgment, physician approval, medical-physics checks, or the treatment delivery system.
- MRI safety labeling is generally not applicable to the software itself, although any connected MRI scanner or hardware must be evaluated under its own safety requirements.
Frequently Asked Questions
What is syngo dosimetrist workspace v2 7 used for?
It is used for planning and managing radiation therapy treatments, helping to optimize radiation doses for cancer patients.
What specialties typically use this device?
Radiation oncologists and dosimetrists in oncology departments primarily use this device.
What are the FDA-cleared indications?
It is indicated for use in planning radiation therapy treatments to deliver precise radiation doses to tumors while minimizing exposure to healthy tissues.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.