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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 ?
510(k)
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.
FDA-Cleared Indications
- The device is indicated for clinical event interface functions as described in its FDA-cleared labeling.
- The available record does not provide enough detail to state additional procedure-specific indications.
Clinical Applications
- Integration of clinical event information with compatible clinical systems.
- Collection or communication of procedural event data in healthcare environments.
- Use by trained healthcare professionals in hospitals or other clinical settings, according to the manufacturer’s instructions.
Practical Considerations
- Confirm compatibility with the hospital’s monitoring, information-management, and clinical documentation systems before use.
- Use only according to the current manufacturer’s instructions and facility policies.
- The available record does not establish that the device is an implant, catheter, or other patient-contacting device.
- MRI safety, electrical safety, software interoperability, and environmental limitations should be verified in the current product documentation.
- Do not infer tumor-ablation, oncology, or other procedure-specific use without reviewing the complete FDA-cleared labeling.
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.