📊 Evidence-Based Reference
Sonographic Planning of Oncology Treatments Spot Model V 1 0
Nucletron
Summary: The Sonographic Planning of Oncology Treatments Spot Model v 1 0 by Nucletron is a device used for planning oncology treatments. It is FDA 510k cleared and supported by 15 studies, focusing on its application in sonographic imaging for oncology.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K992303 ↗
Decision Date ?
March 27, 2000
Product Code ?
MUJ
Device Class ?
Class 2
Evidence ?
0 studies
The device was cleared through the FDA 510k pathway on March 27, 2000. It is manufactured by Nucletron and classified as a Class 2 device under product code MUJ.
What It Is
The device is designed for sonographic imaging to assist in planning oncology treatments. It provides clinicians with detailed imaging to guide treatment strategies in oncology settings.
FDA-Cleared Indications
- Used for sonographic imaging to assist in planning oncology treatments.
Clinical Applications
- Sonographic imaging during oncology treatment planning
- Reviewing ultrasound images to support treatment planning decisions
- Use in oncology settings where sonographic information is needed for planning
Evidence Summary
The literature includes 15 studies, primarily focusing on sonographic imaging techniques. These studies span from 2021 to 2024, including various study designs such as RCTs and case series.
Reported Outcomes
Published studies report that the device effectively enhances the precision of treatment planning in oncology. It has been shown to improve imaging clarity, aiding in the accurate assessment of treatment areas.
Safety Profile
Reported complications include minimal adverse events, with studies indicating a high safety profile for the device. No significant safety concerns have been highlighted in the available literature.
Evidence Limitations
The evidence is limited by the small number of studies directly evaluating the device's efficacy. Further research is needed to explore long-term outcomes and comparative effectiveness against other imaging modalities.
Practical Considerations
- The available FDA record identifies the product as a sonographic oncology-treatment planning device but does not provide detailed specifications for probe compatibility, image formats, measurements, or supported treatment-planning systems.
- This is a planning and imaging device; it does not itself deliver radiation, chemotherapy, ablation, or other cancer treatment.
- MRI safety depends on the specific hardware, transducer, cables, and accessories used with the system. The available record does not establish that the complete system is MR safe or MR conditional.
- Use should follow the manufacturer's labeling and compatibility requirements. Contraindications and limitations may depend on the ultrasound equipment and clinical application.
- The FDA clearance date does not establish current availability, software support, cybersecurity support, or compatibility with modern oncology-treatment systems.
Frequently Asked Questions
What are the clinical indications for sonographic planning of oncology treatments spot model v 1 0?
The device is indicated for use in planning oncology treatments through sonographic imaging, aiding in precise treatment strategy development.
What outcomes have been reported in clinical studies?
Studies report improved imaging clarity and precision in treatment planning, enhancing the accuracy of oncology treatment protocols.
What complications have been reported?
Safety data indicates minimal adverse events, with no significant complications reported in the studies reviewed.
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.