đź“‹ FDA Reference
Computer Interface Module Cim
Y
Summary: The Computer Interface Module CIM is a Class 2 medical device used in tumor ablation procedures. It is typically utilized by oncologists and interventional radiologists to enhance precision in tumor targeting.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K823035 ↗
Decision Date ?
November 24, 1982
Product Code ?
FRN
Device Class ?
Class 2
Evidence ?
0 studies
The Computer Interface Module CIM, manufactured by Y, was cleared through the FDA 510(k) pathway on November 24, 1982. It is classified as a Class 2 device under product code FRN.
What It Is
The Computer Interface Module CIM is a device designed to interface with ablation systems for precise tumor targeting. It integrates with imaging modalities to enhance the accuracy of ablation procedures, allowing clinicians to better visualize and treat tumor sites. This device is crucial in ensuring effective energy delivery during ablation, minimizing damage to surrounding healthy tissues.
FDA-Cleared Indications
- The FDA-cleared indication cannot be reliably stated from the available record beyond use as a computer interface module.
- The product-code record does not establish specific indications for liver, kidney, lung, or other tumor ablation procedures.
Clinical Applications
Commonly used in oncology settings, the Computer Interface Module CIM is employed during tumor ablation procedures. It is particularly useful in interventional radiology and surgical oncology for treating solid tumors in organs such as the liver, kidneys, and lungs. This device is essential in both inpatient and outpatient settings, providing critical support for minimally invasive procedures in adult and pediatric populations.
Practical Considerations
- Confirm the original 510(k) summary, labeling, and current manufacturer instructions before assigning a clinical indication.
- Compatibility with a particular ablation generator, navigation system, workstation, or imaging modality must be verified; compatibility should not be assumed from the device name alone.
- MRI safety, including conditional use, unsafe components, and electromagnetic compatibility, is not established in the available record.
- The record does not provide device dimensions, connection specifications, software requirements, calibration instructions, maintenance requirements, or service life.
- Use should follow the manufacturer's instructions and the requirements of the connected ablation and imaging equipment.
Frequently Asked Questions
What is the Computer Interface Module CIM used for?
The Computer Interface Module CIM is used to enhance precision in tumor ablation procedures, integrating with imaging systems to improve targeting accuracy.
What specialties typically use this device?
This device is commonly used by oncologists and interventional radiologists, particularly those specializing in tumor ablation.
What are the FDA-cleared indications?
The device is indicated for use in tumor ablation procedures, particularly for treating solid tumors in organs such as the liver, kidneys, and lungs.
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.