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decimal3d
.Decimal
Summary: The decimal3d is a medical device used for improving efficiency in clinical electron simulations, primarily in radiation oncology. It is utilized by healthcare professionals to streamline treatment planning processes.
FDA Clearance Information
Pathway
510K
Number
K192554 ↗
Decision Date
December 13, 2019
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The decimal3d by .Decimal was cleared through the FDA 510k pathway on December 13, 2019. It is a Class 2 device under product code MUJ.
What It Is
The decimal3d is a 3-dimensional stereoscopic camera system designed to enhance clinical electron simulation and treatment planning. It allows simulations to be conducted outside the treatment vault, offering flexibility in patient positioning and reducing the need for machine time. This device integrates advanced imaging technology to facilitate accurate and efficient treatment planning.
Clinical Applications
The decimal3d is commonly used in radiation oncology settings for treatment planning and simulation. It is particularly useful in scenarios where electron beam therapy is indicated, allowing clinicians to perform simulations in various settings. This device is beneficial for patient populations requiring precise and efficient treatment planning, such as those undergoing cancer treatment.
Indications for Use
The decimal3d is indicated for use in improving the efficiency of clinical electron simulations. It is suitable for patients who require electron beam therapy, allowing for more flexible and efficient treatment planning.
Practical Considerations
The decimal3d system is compatible with various patient positioning devices and can be used in any room with a flat surface. Clinicians should consider the spatial requirements and ensure compatibility with existing treatment planning systems.
Related Literature
The linked study evaluated the implementation of the decimal3d stereoscopic camera system for clinical electron simulation and treatment planning. It demonstrated that simulations could be moved from the treatment vault to any suitable room, improving efficiency. The study found that the system's treatment parameters were consistent with those used in delivery, though further research could explore broader applications and long-term outcomes.
Frequently Asked Questions
What is decimal3d used for?
The decimal3d is used for improving the efficiency of clinical electron simulations and treatment planning in radiation oncology.
What specialties typically use this device?
Radiation oncology specialists typically use the decimal3d for treatment planning and simulation.
What are the FDA-cleared indications?
The decimal3d is cleared for use in enhancing the efficiency of clinical electron simulations, particularly for patients undergoing electron beam therapy.
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.