Skip to content

RII Multi-function Infrared Thermometer, Model TH52Z

by Radiant Innovation Inc. Taiwan EUDAMED510(k)

510(k) K162083 Product code FLL

Overview

The RII Multi-function Infrared Thermometer, Model TH52Z is a medical device that measures temperature using infrared technology. It can measure body temperature via forehead or ear modes, as well as surface temperatures of objects in scan mode.

The device is supplied with a user manual and is authorized under FDA 510K and MDR regulations. It features temperature measurement ranges of 3442.2°C for body temperature and -2280°C for surface temperature, and includes additional functions such as a stopwatch and real-time clock.

Summary written by AI from registry data, 18 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically 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.

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK162083 Date9 Jan 2017ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceAustriaHungaryRomaniaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceSloveniaBulgariaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaPortugalSpainSpainItalyUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSpainSpainCroatiaGreeceUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaMaltaCyprusUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
FLL
FDA applicant
Radiant Innovation, Inc.
Device Class
Class II
Regulation
21 CFR Part 880.2910
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Other devices from Radiant Innovation Inc.

See all devices from Radiant Innovation Inc. →

Questions

  • What temperature measurement modes does the RII Multi-function Infrared Thermometer offer?

    The device measures body temperature via forehead or ear modes, and can also measure surface temperatures of objects in scan mode.

  • What are the temperature measurement ranges for body and surface temperatures?

    Body temperature can be measured in the range of 34~42.2°C, while surface temperature can be measured in the range of -22~80°C.

  • What additional functions does the RII Multi-function Infrared Thermometer include?

    The device includes additional functions such as a stopwatch and real-time clock.

  • What is included in the supply of the RII Multi-function Infrared Thermometer?

    The device is supplied with a user manual.

  • What regulatory authorizations does the RII Multi-function Infrared Thermometer have?

    The device is authorized under FDA 510K and MDR regulations.

Properties & raw data

Show properties, registry sources and raw records

Sources (2)

  • FDA 510(k) K162083 24 fields · synced 22 Oct 2026
  • EUDAMED 1 fields · synced 18 May 2026