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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
510K
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.
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.
Indications for Use
The FDA-cleared indications for the datacell 18ms involve its use in TACE procedures for treating liver cancer. It is designed for patients with localized liver tumors who require targeted chemotherapy delivery.
Practical Considerations
The datacell 18ms is compatible with standard catheter systems used in TACE. Clinicians should ensure proper sizing and placement to optimize treatment outcomes. Familiarity with interventional techniques is essential for effective use.
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.