đź“‹ FDA Reference
Kodak Ektascan Xlp Preliminary DV2000 Interface
Eastman Kodak
Summary: The Kodak Ektascan XLP Preliminary DV2000 Interface is a medical imaging device used primarily for tumor ablation procedures. It is utilized by radiologists and oncologists in clinical settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K912454 ↗
Decision Date ?
September 27, 1991
Product Code ?
JAK
Device Class ?
Class 2
Evidence ?
0 studies
The Kodak Ektascan XLP Preliminary DV2000 Interface was cleared through the FDA 510(k) pathway on September 27, 1991. Manufactured by Eastman Kodak, it is classified as a Class 2 medical device.
What It Is
The Kodak Ektascan XLP Preliminary DV2000 Interface is an imaging device designed to assist in the visualization of tumors during ablation procedures. It integrates with existing imaging systems to provide enhanced imaging capabilities, facilitating precise targeting and monitoring of tumor ablation. This device is particularly useful in procedures requiring high-resolution imaging to ensure accurate treatment delivery.
FDA-Cleared Indications
- The FDA record lists the device under product code JAK and provides the indication text as “Statement.”
- The available record does not include a detailed FDA-cleared indication describing a specific disease, procedure, body region, or tumor-ablation use.
Clinical Applications
- Use as part of a compatible medical imaging system in clinical settings.
- Support image display, transfer, or interface functions when incorporated into a compatible Kodak Ektascan imaging system.
- Use by trained healthcare professionals according to the labeling and compatibility requirements for the specific system.
Practical Considerations
- Verify compatibility with the imaging equipment, software, cables, and workstation before clinical use.
- The available FDA record does not establish that the interface independently guides, monitors, or performs tumor ablation.
- This is an imaging-system interface rather than an ablation catheter, needle, probe, or energy-delivery device.
- MRI safety cannot be determined from the available record; the interface and all connected components should be evaluated under the facility's MRI safety policy.
- Follow the manufacturer's labeling, electrical-safety requirements, maintenance instructions, and institutional medical-device procedures.
Frequently Asked Questions
What is Kodak Ektascan XLP Preliminary DV2000 Interface used for?
It is used for imaging during tumor ablation procedures to ensure precise targeting and monitoring.
What specialties typically use this device?
Radiologists and oncologists, particularly those specializing in interventional radiology and oncology.
What are the FDA-cleared indications?
The device is indicated for use in tumor ablation procedures, providing enhanced imaging to assist in treatment delivery.
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.