Data / Medical devices / Taiwan / Radiant Innovation Inc.
Radiant Innovation Inc.: FDA-registered device maker in HSINCHU Hsinchu(County), Taiwan, 11 510(k) clearances
Radiant Innovation Inc. is registered with the FDA (registration 9710548) in HSINCHU Hsinchu(County), Taiwan. It lists 2 device types. The FDA files 11 510(k) clearances under its listings, the newest dated June 5, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9710548
- FEI number
- 3003515005
- Address
- 1F, No.3, Industrial E. 9TH RD Science-Based Industrial Park, HSINCHU Hsinchu(County), Taiwan, 30075
- Owner or operator
- RADIANT INNOVATION, INC. (9045429)
- Roles
- Specification developer
- First device listed
- November 25, 2007
- Registered through
- 2027
- Brand names listed
- Easy Read Dual Mode Forehead Thermometer, Model TH091, Easy Read Dual Mode Thermometer, Model TH095, FT90, INFRARED EAR THERMOMETER, Infrared Ear Thermometer Probe Cover, Model MDS9701, Infrared Ear Thermometer Probe Cover, Model PC 840, Infrared Ear Thermometer Probe Cover, Model PC7200, Infrared Ear Thermometer Probe Cover, Model PCL A40 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Clinical Electronic Thermometer | SDV | 2 | Specification developer | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 5, 2024 | K240648 | Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE) | FLL | Substantially Equivalent | Radiant Innovation, Inc. | accessdata.fda.gov |
| January 9, 2017 | K162083 | RII Multi-function Infrared Thermometer, Model TH52Z | FLL | Substantially Equivalent | Radiant Innovation, Inc. | accessdata.fda.gov |
| July 17, 2012 | K121428 | NON-CONTACT CLINICAL THERMOMETER | FLL | Substantially Equivalent | Radiant Innovation, Inc. | accessdata.fda.gov |
| December 6, 2011 | K111637 | INFRARED EAR THERMOMETER | FLL | Substantially Equivalent | Radiant Innovation, Inc. | accessdata.fda.gov |
| December 10, 2010 | K102187 | RII INFRARED EAR THERMOMETER, | FLL | Substantially Equivalent | Radiant Innovation, Inc. | accessdata.fda.gov |
| June 29, 2010 | K101253 | RII INFRARED EAR THERMOMETER, MODEL: TH60N | FLL | Substantially Equivalent | Radiant Innovation, Inc. | accessdata.fda.gov |
| April 20, 2007 | K070976 | RII INFRARED EAR THERMOMETER, MODEL TH01BN | FLL | Substantially Equivalent | Radiant Innovation, Inc. | accessdata.fda.gov |
| November 17, 2006 | K063185 | RII INFRARED EAR THERMOMETER, MODELS TH5XY SERIES | FLL | Substantially Equivalent | Radiant Innovation, Inc. | accessdata.fda.gov |
| September 16, 2004 | K040377 | RII INFRARED EAR THERMOMETER, MODELS THXXN SERIES | FLL | Substantially Equivalent | Radiant Innovation, Inc. | accessdata.fda.gov |
| February 28, 2002 | K020504 | INFRARED EAR THERMOMETER, MODELS TH88 SERIES | FLL | Substantially Equivalent | Radiant Innovation, Inc. | accessdata.fda.gov |
| September 17, 2001 | K011059 | INFARED EAR THERMOMETER, MODEL TH8 SERIES | FLL | Substantially Equivalent | Radiant Innovation, Inc. | accessdata.fda.gov |
Compare with other makers
Updated June 5, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.