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Avita Scaneo IR Thermometer TS2X & TS3X Series

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K092958

by Avita Corporation

Identifiers

510(k) Number
K092958 FDA 510(k)
FDA Product Code
FLL FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.2910 FDA 510(k)
Regulation Number
880.2910 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Avita Scaneo IR Thermometer TS2X & TS3X Series is a handheld, non-contact infrared thermometer designed for measuring natural thermal infrared radiation. Models TS2X and TS3X measure tympanic temperature via the ear canal, while the TS3X also includes temporal artery measurement over the forehead. This device converts detected infrared energy into a temperature reading for clinical assessment.

The device is battery-operated, non-sterile, and reusable, intended for intermittent temperature monitoring in home or patient-care settings. Supplied as a single-use or reusable unit (as per manufacturer specifications), it adheres to FDA 510(k) clearance under Special Review (K092958) and complies with the Medical Device Directive (MDD). No MRI safety classification or additional sterility requirements are specified.

Frequently asked questions

What are the key differences between the TS2X and TS3X models of the Avita Scaneo IR Thermometer?

The TS2X model measures tympanic temperature via the ear canal, while the TS3X includes an additional feature for measuring temporal artery temperature over the forehead. Both models are non-contact infrared thermometers designed for intermittent temperature monitoring in home or patient-care settings.

Is this device reusable, and if so, how should it be maintained?

Yes, the Avita Scaneo IR Thermometer is reusable as per manufacturer specifications. Since it is non-sterile, it is intended for intermittent use rather than repeated contact with patients. Maintenance instructions are not detailed in the provided data, but standard battery-operated device care (e.g., avoiding moisture exposure) should apply.

What regulatory pathways does this device follow, and what does that mean for buyers?

The device holds FDA 510(k) clearance under Special Review (K092958) and complies with the Medical Device Directive (MDD). This means it has been deemed substantially equivalent to a predicate device and meets EU safety and performance requirements, though buyers should verify local regulatory compliance for their specific market.

Can this thermometer be used in an MRI environment, and if not, why?

The device does not have an MRI safety classification specified in the provided data, which implies it may not be MRI-safe. Non-contact infrared thermometers often contain electronic components or batteries that could pose risks in MRI environments, so use in such settings should be avoided unless confirmed safe by the manufacturer.

What types of temperature measurements does this device support, and how is it supplied?

The device supports tympanic (ear canal) temperature measurement (TS2X and TS3X) and temporal artery (forehead) measurement (TS3X only). It is supplied as either a single-use or reusable unit, depending on the manufacturer’s specifications for the specific model and intended use case.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Avita Scaneo Ir Thermometer, Models Ts2x & Ts3x Series, Avita Scaneo Ir Thermometer, Models Ts2x & Ts3x Series 510 (k) FDA ..., Avita Scaneo Ir Thermometer Model Ts4x Series

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Avita Corporation

Sources (2)

  • FDA 510(k) K092958 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026