đź“‹ FDA Reference
6400st interface module-rs232
Bird Products
Summary: The 6400st interface module-rs232 is a medical device used in tumor ablation procedures. It is typically utilized by oncologists and interventional radiologists to interface with other medical equipment.
FDA Clearance Information
Pathway
510K
Number
K880721 ↗
Decision Date
April 14, 1988
Product Code
CBK
Device Class
Class 2
Evidence
0 studies
The 6400st interface module-rs232 by Bird Products was cleared via the FDA 510(k) pathway on April 14, 1988. It is classified as a Class 2 device under product code CBK.
What It Is
The 6400st interface module-rs232 is a specialized device designed to facilitate communication between ablation systems and other medical equipment. It uses the RS232 interface standard, which is commonly employed in medical settings for reliable data transmission. This device plays a crucial role in ensuring the precise control and monitoring of ablation procedures.
Clinical Applications
This device is primarily used in oncology settings, particularly in procedures involving tumor ablation. It is essential in interventional radiology suites where precise control of ablation equipment is necessary. The device is suitable for use in hospitals and specialized cancer treatment centers, catering to adult and pediatric populations undergoing tumor ablation therapy.
Indications for Use
The FDA indications suggest that this device is intended for use in tumor ablation procedures. It is suitable for patients requiring precise ablation of cancerous tissues, often in conjunction with other imaging and monitoring systems.
Practical Considerations
The 6400st interface module-rs232 typically requires compatibility with RS232 standard equipment. Clinicians should ensure that their existing systems can interface with this module. Proper training on the device's integration into the ablation workflow is recommended to optimize its use.
Frequently Asked Questions
What is 6400st interface module-rs232 used for?
It is used to facilitate communication between tumor ablation systems and other medical equipment, ensuring precise control during procedures.
What specialties typically use this device?
Oncologists and interventional radiologists typically use this device in tumor ablation procedures.
What are the FDA-cleared indications?
The device is cleared for use in tumor ablation procedures, aiding in the precise ablation of cancerous tissues.
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.