đź“‹ FDA Reference
Imation Model 9410 Network Interface
Imation
Summary: The Imation Model 9410 Network Interface is a Class 1 medical device used in tumor ablation procedures. It is typically utilized by oncologists and interventional radiologists to facilitate network communication in ablation devices.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K973303 ↗
Decision Date ?
November 25, 1997
Product Code ?
LMD
Device Class ?
Class 1
Evidence ?
0 studies
The Imation Model 9410 Network Interface was cleared through the FDA 510(k) pathway on November 25, 1997. It is manufactured by Imation and classified as a Class 1 device under product code LMD.
What It Is
The Imation Model 9410 Network Interface is a medical device designed to enable network communication for tumor ablation systems. It facilitates the integration and data exchange between various components of ablation devices, ensuring seamless operation during procedures. This device is crucial for maintaining the accuracy and efficiency of ablation therapies, which are used to destroy cancerous tissues.
FDA-Cleared Indications
- Intended for use as a network interface in a tumor-ablation system, based on the available FDA record and product-code information.
Clinical Applications
- Supporting communication between components of a tumor-ablation system.
- Facilitating data exchange within an ablation procedure setup.
- Use in clinical environments where compatible tumor-ablation equipment is operated.
Practical Considerations
- The available record does not specify supported network standards, connectors, dimensions, operating conditions, or compatibility with particular ablation generators.
- Compatibility should be confirmed with the complete ablation system and the current manufacturer or facility biomedical-engineering documentation before use.
- This device is a network interface, not an ablation generator, applicator, catheter, needle, or implantable device.
- The record does not state that the device is MRI safe or MR conditional; it should not be taken into an MRI environment unless current labeling specifically permits it.
- The FDA record does not provide a service life, replacement interval, or maintenance schedule. Follow the manufacturer’s instructions and institutional equipment policies.
Frequently Asked Questions
What is Imation Model 9410 Network Interface used for?
It is used to facilitate network communication in tumor ablation devices, ensuring effective data exchange during procedures.
What specialties typically use this device?
Oncologists and interventional radiologists commonly use this device in tumor ablation procedures.
What are the FDA-cleared indications?
It is indicated for use in supporting network communication for tumor ablation procedures, ensuring effective device integration.
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.