đź“‹ FDA Reference
Computer Interface Il 814
Instrumentation Laboratory
Summary: The Computer Interface IL 814 is a Class 1 medical device used in tumor ablation procedures. It is primarily utilized by oncologists and interventional radiologists in clinical settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K781173 ↗
Decision Date ?
September 14, 1978
Product Code ?
JQP
Device Class ?
Class 1
Evidence ?
0 studies
The Computer Interface IL 814 was cleared through the FDA 510k pathway on September 14, 1978. Manufactured by Instrumentation Laboratory, it is classified as a Class 1 device.
What It Is
The Computer Interface IL 814 is a medical device designed to facilitate tumor ablation procedures. It serves as an interface for computer systems used in the precise targeting and destruction of tumor tissues. The device integrates with existing medical equipment to enhance the accuracy and effectiveness of ablation techniques.
FDA-Cleared Indications
- The available FDA record identifies the device as a computer interface.
- The supplied record does not include the complete FDA-cleared indication statement.
- Tumor-ablation indications cannot be confirmed from the available record alone.
Clinical Applications
This device is commonly used in oncology and interventional radiology for the ablation of tumors. It is particularly useful in settings where precision is critical, such as in the treatment of liver, kidney, or lung tumors. The device supports clinicians in delivering targeted therapy to minimize damage to surrounding healthy tissues.
Practical Considerations
- Confirm the original FDA labeling, operator manual, and predicate-device information before clinical use.
- Verify electrical, software, hardware, and communication compatibility with any connected medical equipment.
- Because this is a computer interface rather than an ablation catheter or energy-delivery device, it should not be described as directly treating tumors.
- MRI safety, electromagnetic compatibility, sterilization requirements, and operating-environment restrictions are not established in the supplied record.
- Check the device's current service status, calibration requirements, and institutional equipment policies because the clearance dates from 1978.
Related Literature
The linked study, 'Service-oriented science,' explores the impact of service-oriented architectures on scientific research. It highlights how these architectures enable broader access to data and tools, facilitating automation and collaboration. While the study is not directly related to the device, it underscores the importance of integrating advanced information systems in clinical practice.
Frequently Asked Questions
What is Computer Interface IL 814 used for?
It is used for tumor ablation procedures, aiding in the precise targeting and destruction of tumor tissues.
What specialties typically use this device?
Oncology and interventional radiology specialists typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in tumor ablation procedures, providing a minimally invasive treatment option for certain 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.