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ergo srs
3D Line U
Summary: The ergo srs by 3D Line U is a stereotactic radiosurgery device primarily used in radiosurgical procedures. Key evidence includes feasibility and initial clinical outcomes in various cancer treatments.
FDA Clearance Information
Pathway
510K
Number
K031281 ↗
Decision Date
December 23, 2003
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The ergo srs was cleared by the FDA via the 510(k) pathway on December 23, 2003. It is manufactured by 3D Line U and classified as a Class 2 device under product code MUJ.
What It Is
The ergo srs is a stereotactic radiosurgery system designed for precise targeting of tumors and lesions. It is used in conjunction with linear accelerators to deliver high-dose radiation therapy to specific areas, minimizing exposure to surrounding healthy tissue.
Clinical Applications
Commonly used in the treatment of intracranial and extracranial tumors, the ergo srs is applied in clinical scenarios such as liver metastases and oligometastatic breast and gynecological cancers. It is often utilized in settings requiring high precision and control.
Evidence Summary
The available literature includes three studies published between 2015 and 2019, focusing on the feasibility and initial clinical outcomes of the ergo srs in radiosurgery. These studies explore its application in various cancer treatments.
Reported Outcomes
Published studies report the feasibility of using the ergo srs in radiosurgery for liver metastases and oligometastatic cancers. Initial clinical outcomes indicate effective target volume coverage and dose delivery, with promising results in tumor control.
Safety Profile
Reported complications include general radiosurgery-related adverse events, though specific safety data is limited in the provided studies. Further research is needed to comprehensively assess long-term safety profiles.
Evidence Limitations
The evidence is limited by small sample sizes and a lack of long-term follow-up data. Further research is necessary to validate initial findings and explore the full safety and efficacy profile of the ergo srs.
Frequently Asked Questions
What are the clinical indications for ergo srs?
The ergo srs is indicated for use in stereotactic radiosurgery for treating intracranial and extracranial tumors, including liver metastases and oligometastatic cancers.
What outcomes have been reported in clinical studies?
Studies report effective target volume coverage and promising tumor control outcomes in radiosurgery applications.
What complications have been reported?
Reported complications include general adverse events associated with radiosurgery, though specific safety data is limited.
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.