📋 FDA Reference
Kodak Ektascan Digital Interface for at T
Eastman Kodak
Summary: The Kodak Ektascan Digital Interface is a medical device used for digital imaging in tumor ablation procedures. It is primarily utilized by radiologists and oncologists to enhance imaging capabilities during treatment.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K911405 ↗
Decision Date ?
April 23, 1991
Product Code ?
LMD
Device Class ?
Class 1
Evidence ?
0 studies
The Kodak Ektascan Digital Interface was cleared through the FDA 510(k) pathway on April 23, 1991. Manufactured by Eastman Kodak, it is classified as a Class 1 device under product code LMD.
What It Is
The Kodak Ektascan Digital Interface is a digital imaging device designed to integrate with ablation systems for tumor treatment. It facilitates the capture and processing of high-quality images, aiding clinicians in accurately targeting and monitoring tumors during ablation procedures. This device enhances visualization, which is crucial for effective treatment planning and execution.
FDA-Cleared Indications
- The FDA record identifies the device under product code LMD as a digital imaging-related device.
- The available record does not provide sufficient labeling detail to state a more specific clinical indication.
Clinical Applications
- Supporting digital image acquisition or image display when used with compatible imaging equipment.
- Providing an interface between specified imaging-system components and digital image-processing equipment.
Practical Considerations
- Use only with imaging systems and accessories identified as compatible by the manufacturer or facility documentation.
- The available FDA record does not establish compatibility with modern PACS, CT, MRI, ultrasound, or ablation platforms.
- This is an imaging interface rather than an ablation catheter, probe, implant, or therapeutic energy-delivery device.
- MRI safety cannot be determined from the available record; the device and connected equipment should not enter the MRI environment unless specifically labeled for MRI use.
- Verify current serviceability, software support, electrical safety, image quality, and data-transfer compatibility before clinical use.
Frequently Asked Questions
What is Kodak Ektascan Digital Interface used for?
It is used for digital imaging in tumor ablation procedures to enhance visualization and accuracy.
What specialties typically use this device?
Radiologists and oncologists commonly use this device in oncology and radiology departments.
What are the FDA-cleared indications?
The device is indicated for use in digital imaging to support tumor ablation procedures.
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.