📋 FDA Reference
Datacell 18ms
Danam Electronics
Summary: The datacell 18ms is a medical device used in transcatheter arterial chemoembolization (TACE) procedures. It is primarily utilized by interventional radiologists to treat liver cancer.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K945678 ↗
Decision Date ?
September 12, 1995
Product Code ?
GKZ
Device Class ?
Class 2
Evidence ?
0 studies
The datacell 18ms was cleared through the FDA 510(k) pathway on September 12, 1995. Manufactured by Danam Electronics, it is classified as a Class 2 device under product code GKZ.
What It Is
The datacell 18ms is a specialized device used in TACE procedures, which are minimally invasive treatments for liver cancer. It works by delivering chemotherapy directly to the liver tumor while blocking its blood supply, enhancing the treatment's efficacy. This device is crucial in interventional radiology for targeting tumors with precision.
FDA-Cleared Indications
- The FDA indication available in this record is listed only as "Statement" and does not provide a specific intended use.
Clinical Applications
Commonly used in interventional radiology, the datacell 18ms is employed in hospitals and cancer treatment centers. It is particularly beneficial for patients with hepatocellular carcinoma who are not candidates for surgery. The device allows for targeted therapy, minimizing systemic exposure and side effects.
Practical Considerations
- The record does not provide verified device specifications, dimensions, catheter compatibility, or delivery-system details.
- Do not infer TACE compatibility, embolic capability, or chemotherapy-delivery functionality without reviewing the original FDA 510(k) summary, labeling, and manufacturer instructions for use.
- MRI safety status is not provided. Confirm MR Safe, MR Conditional, or MR Unsafe labeling before exposing the device or any implanted component to MRI.
- Contraindications, warnings, shelf life, sterilization method, and handling requirements are not available in the supplied record.
- The FDA clearance date is recorded as September 12, 1995, but current availability, labeling, and manufacturer support should be independently verified.
Frequently Asked Questions
What is datacell 18ms used for?
The datacell 18ms is used in TACE procedures to treat liver cancer by delivering chemotherapy directly to the tumor.
What specialties typically use this device?
Interventional radiologists primarily use the datacell 18ms in cancer treatment settings.
What are the FDA-cleared indications?
The device is indicated for use in TACE procedures for patients with liver cancer, specifically for localized tumor treatment.
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.