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cobe accessory interface module aim
Cobe Laboratories
Summary: The Cobe Accessory Interface Module AIM is a medical device used primarily in tumor ablation procedures. It is utilized by healthcare professionals in oncology and interventional radiology to assist in the precise targeting and treatment of tumors.
FDA Clearance Information
Pathway
510K
Number
K861860 ↗
Decision Date
July 18, 1986
Product Code
KRL
Device Class
Class 2
Evidence
0 studies
The Cobe Accessory Interface Module AIM was cleared through the FDA 510(k) pathway on July 18, 1986. Manufactured by Cobe Laboratories, it is classified as a Class 2 device under product code KRL.
What It Is
The Cobe Accessory Interface Module AIM is an accessory device designed to interface with ablation systems used in the treatment of tumors. It facilitates the connection and communication between various components of the ablation setup, ensuring precise control and delivery of energy to the target tissue. This device is crucial in maintaining the accuracy and safety of ablation procedures.
Clinical Applications
This device is commonly used in oncology and interventional radiology settings, particularly for procedures involving tumor ablation. It is suitable for use in hospitals and specialized cancer treatment centers. The primary patient population includes individuals diagnosed with solid tumors that are amenable to ablation therapy, such as liver, kidney, or lung tumors.
Indications for Use
The FDA indications suggest that the Cobe Accessory Interface Module AIM is intended for use in procedures where tumor ablation is indicated. This includes patients with tumors that are accessible and can be treated with thermal or other forms of energy ablation.
Practical Considerations
Clinicians should ensure compatibility with existing ablation systems when integrating the Cobe Accessory Interface Module AIM. Proper training in its use is essential to maximize the precision and effectiveness of tumor ablation procedures. Consideration of the device's interface capabilities is important for seamless operation.
Frequently Asked Questions
What is the Cobe Accessory Interface Module AIM used for?
It is used to facilitate the connection and communication between components of ablation systems during tumor ablation procedures.
What specialties typically use this device?
Oncology and interventional radiology are the primary specialties that use this device.
What are the FDA-cleared indications?
The device is indicated for use in tumor ablation procedures, assisting in the precise targeting and treatment of tumors.
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.