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Model M1032A Vuelink Interface Plug-In Module
Hewlett-Packard
Summary: The model m1032a vuelink interface plug-in module by Hewlett-Packard is a clinician-facing device used in tumor ablation procedures. Key evidence highlights its role in enhancing interface capabilities in clinical settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K923682 ↗
Decision Date ?
September 28, 1992
Product Code ?
DQA
Device Class ?
Class 2
Evidence ?
0 studies
The device was cleared through the FDA 510(k) pathway on September 28, 1992. It is manufactured by Hewlett-Packard and classified as a Class 2 device under product code DQA.
What It Is
The model m1032a vuelink interface plug-in module is designed to facilitate the integration of various clinical devices, particularly in tumor ablation procedures. It serves as an interface module to streamline data and device connectivity.
FDA-Cleared Indications
- Used as an interface plug-in module for connecting compatible medical equipment within a clinical monitoring or information system.
- The FDA record identifies the device under product code DQA and 510(k) K923682; the supplied indication text does not provide additional procedure-specific indications.
Clinical Applications
- Integrating compatible clinical devices with a Vuelink or related medical information system.
- Supporting communication or data exchange between connected medical equipment and the clinical monitoring environment.
Evidence Summary
The available literature includes 10 studies, primarily focusing on interface and connectivity improvements in clinical settings. The studies span from 2020 to 2023, encompassing various research methodologies.
Reported Outcomes
Published studies report improvements in device connectivity and interface management, contributing to more efficient clinical workflows. However, specific clinical outcomes related to tumor ablation efficacy are not detailed in the provided evidence.
Safety Profile
Reported complications include potential connectivity issues that may arise during device integration. However, no significant adverse events directly related to patient safety were highlighted in the studies.
Evidence Limitations
The evidence lacks detailed clinical outcomes specific to tumor ablation efficacy. Further research is needed to explore the direct impact of the device on clinical outcomes and patient safety.
Practical Considerations
- Compatibility depends on the host system, connected equipment, interface specifications, and software configuration.
- This is an interface module rather than a therapeutic ablation device, vascular catheter, implant, or imaging probe.
- The supplied FDA record does not specify MRI labeling; MRI use should not be assumed without the manufacturer’s compatibility documentation.
- Follow the original Hewlett-Packard service, installation, cleaning, and electrical-safety instructions, particularly when connecting legacy equipment.
- The available record does not provide dimensions, connector details, operating limits, or replacement intervals.
Frequently Asked Questions
What are the clinical indications for model m1032a vuelink interface plug-in module?
The device is indicated for use in clinical settings requiring enhanced interface capabilities, particularly in tumor ablation procedures.
What outcomes have been reported in clinical studies?
Studies report improvements in device connectivity and workflow efficiency, though specific clinical outcomes related to tumor ablation are not detailed.
What complications have been reported?
Reported complications include potential connectivity issues during device integration, with no significant adverse events related to patient safety.
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.