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Securus
Summary: The IRTS Thermal Imaging Probe by Securus is a Class 2 medical device used for tumor ablation procedures. It is typically utilized by oncologists and surgeons in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K152402 ↗
Decision Date
March 4, 2016
Product Code
FLL
Device Class
Class 2
Evidence
0 studies
The IRTS Thermal Imaging Probe, manufactured by Securus, received FDA clearance via the 510(k) pathway on March 4, 2016. It is classified as a Class 2 device under product code FLL.
What It Is
The IRTS Thermal Imaging Probe is a medical device designed to assist in the thermal imaging of tissues during tumor ablation procedures. It works by providing real-time thermal data, helping clinicians accurately target and monitor the ablation process. This device is particularly useful in ensuring that the ablation is effective while minimizing damage to surrounding healthy tissues.
Clinical Applications
This device is commonly used in oncology and surgical settings for the treatment of tumors. It is particularly valuable in procedures where precise thermal monitoring is critical, such as in liver, kidney, or lung tumor ablations. The device is used by specialists including oncologists, interventional radiologists, and surgeons, primarily in hospital or specialized clinic environments.
Indications for Use
The FDA has cleared this device for use in procedures requiring thermal imaging during tumor ablation. It is intended for patients undergoing treatment for various types of tumors where precise thermal monitoring can enhance the efficacy and safety of the procedure.
Practical Considerations
Clinicians should ensure compatibility with existing ablation systems and be trained in the interpretation of thermal imaging data. The device may come in different probe sizes to accommodate various patient anatomies and procedural requirements.
Frequently Asked Questions
What is IRTS Thermal Imaging Probe used for?
It is used for providing real-time thermal imaging during tumor ablation procedures to ensure effective treatment.
What specialties typically use this device?
Oncologists, interventional radiologists, and surgeons typically use this device in tumor ablation procedures.
What are the FDA-cleared indications?
The device is indicated for use in thermal imaging during tumor ablation procedures to assist in the precise targeting and monitoring of the ablation process.
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.