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hematology computer-interface viscount
Eko Scann Ab
Summary: The Hematology Computer-Interface Viscount by Eko Scann Ab is a Class 2 medical device used in hematology for tumor ablation. It is typically utilized by oncologists and hematologists in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K822823 ↗
Decision Date
October 18, 1982
Product Code
LKM
Device Class
Class 2
Evidence
0 studies
The Hematology Computer-Interface Viscount was cleared through the FDA 510k pathway on October 18, 1982. Manufactured by Eko Scann Ab, it is classified as a Class 2 device under product code LKM.
What It Is
The Hematology Computer-Interface Viscount is a specialized medical device designed for interfacing with hematology systems to assist in tumor ablation procedures. It integrates with existing hematology equipment to enhance precision and control during ablation. The device is essential for providing accurate data and feedback, which are critical for effective treatment outcomes.
Clinical Applications
This device is commonly used in oncology and hematology departments for the ablation of tumors. It is particularly useful in settings where precise control and monitoring of ablation parameters are necessary. The device is suitable for treating patients with various types of hematological tumors, providing clinicians with enhanced capabilities to target and manage tumor growth.
Indications for Use
The FDA indications suggest that this device is intended for use in the ablation of tumors, specifically within the hematology field. It is designed for patients requiring precise tumor management, often in cases where traditional surgical options are not viable.
Practical Considerations
Clinicians should ensure compatibility with existing hematology systems when integrating the Hematology Computer-Interface Viscount. Proper training on the device's interface and controls is recommended to maximize its efficacy. Consideration of the device's size and setup within the clinical environment is also important for optimal use.
Frequently Asked Questions
What is the Hematology Computer-Interface Viscount used for?
It is used for interfacing with hematology systems to assist in tumor ablation procedures.
What specialties typically use this device?
Oncologists and hematologists typically use this device in clinical settings.
What are the FDA-cleared indications?
The device is cleared for use in the ablation of tumors within the field of hematology.
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.