đź“‹ FDA Reference
spacelabs medical clinical event interface model 91847
Spacelabs Medical
Summary: The Spacelabs Medical Clinical Event Interface Model 91847 is a device used to interface with clinical event data, primarily in the context of tumor ablation procedures. It is typically used by healthcare professionals in oncology and surgical settings.
FDA Clearance Information
Pathway
510K
Number
K062278 ↗
Decision Date
September 19, 2006
Product Code
MSX
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on September 19, 2006, by Spacelabs Medical. It is classified as a Class 2 device under the product code MSX.
What It Is
The Spacelabs Medical Clinical Event Interface Model 91847 is a medical device designed to facilitate the integration and management of clinical event data, particularly in procedures involving tumor ablation. It works by interfacing with various clinical systems to streamline data collection and analysis, enhancing the efficiency and accuracy of clinical workflows.
Clinical Applications
This device is commonly used in oncology settings, particularly during tumor ablation procedures where precise data management is crucial. It is utilized in hospitals and specialized cancer treatment centers, aiding clinicians in monitoring and documenting procedural events. The device supports healthcare providers in delivering targeted therapies to patients with tumors, ensuring accurate treatment delivery and follow-up.
Indications for Use
The FDA-cleared indications suggest that this device is intended for use in managing clinical event data during tumor ablation procedures. It is suitable for patients undergoing these treatments, assisting clinicians in optimizing procedural outcomes.
Practical Considerations
Clinicians should consider the compatibility of the device with existing hospital information systems to ensure seamless integration. Familiarity with the device's interface and data management capabilities is essential for maximizing its utility during procedures.
Frequently Asked Questions
What is Spacelabs Medical Clinical Event Interface Model 91847 used for?
It is used for interfacing and managing clinical event data during tumor ablation procedures.
What specialties typically use this device?
Oncology and surgical specialties, particularly those involved in tumor ablation treatments.
What are the FDA-cleared indications?
The device is indicated for managing clinical event data during tumor ablation procedures, aiding in treatment accuracy and documentation.
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.