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surface temperature scanner
Omega Medical
Summary: The surface temperature scanner by Omega Medical is a device used for measuring surface temperatures, primarily in clinical settings. Key evidence highlights its use in monitoring temperature changes during various medical procedures.
FDA Clearance Information
Pathway
510K
Number
K873010 ↗
Decision Date
November 17, 1987
Product Code
FLL
Device Class
Class 2
Evidence
0 studies
The surface temperature scanner was cleared by the FDA through the 510(k) pathway on November 17, 1987. It is manufactured by Omega Medical and classified as a Class 2 device under product code FLL.
What It Is
The surface temperature scanner is a medical device designed to measure the temperature of surfaces, particularly useful in clinical settings for monitoring temperature changes during procedures. It operates by detecting infrared radiation emitted from the surface.
Clinical Applications
This device is commonly used in scenarios where monitoring surface temperature is critical, such as during tumor ablation procedures or other interventions where temperature control is essential to patient safety and procedure efficacy.
Evidence Summary
The literature includes 15 studies, comprising experimental and various other study types, conducted between 2022 and 2024. These studies explore the device's application in different clinical and experimental settings.
Reported Outcomes
Published studies report that the surface temperature scanner is effective in monitoring temperature changes during medical procedures, such as orthodontic composite removal and guided endodontics. It has been used to assess temperature variations that could affect clinical outcomes.
Safety Profile
Reported complications include potential sensitivity issues due to high-intensity light exposure during procedures, as noted in studies involving intraoral scanners and light-curing units. No other significant adverse events were highlighted in the available evidence.
Evidence Limitations
The evidence base is limited by the small number of studies directly evaluating the device's clinical efficacy and safety. Further research is needed to explore long-term outcomes and broader applications in diverse clinical settings.
Frequently Asked Questions
What are the clinical indications for surface temperature scanner?
The clinical indications are detailed in the FDA documentation, primarily involving scenarios where monitoring surface temperature is critical, such as during tumor ablation.
What outcomes have been reported in clinical studies?
Studies have reported effective monitoring of temperature changes during procedures, which is crucial for maintaining safety and efficacy.
What complications have been reported?
Safety data indicate potential sensitivity issues related to high-intensity light exposure during use, but no other significant complications have been reported.
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.