📊 Evidence-Based Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Measurement of surface temperature.
- Monitoring temperature changes on exposed surfaces during clinical procedures.
Clinical Applications
- Noncontact measurement of skin or other exposed surface temperatures.
- Monitoring temperature changes during procedures that involve tissue heating or cooling.
- Supporting observation of thermal changes during selected tumor-ablation procedures when included in the facility's clinical protocol.
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.
Practical Considerations
- The scanner measures surface temperature and may not accurately represent the temperature of deeper tissue or an internal treatment zone.
- Readings can be affected by distance, angle, movement, emissivity, room temperature, airflow, reflective surfaces, dressings, moisture, and obstruction of the target area.
- Use according to the manufacturer's instructions, including calibration, quality checks, and the specified operating range.
- This record does not establish MRI safety; verify the exact model's MR labeling before use in or near an MRI environment.
- The device is an external scanner rather than an implanted device, catheter, or therapeutic ablation system; it does not itself treat tissue.
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.