Radiant Innovation Inc.
Hsinchu, TW
RADIANT INNOVATION INC. appears in FDA device records in Hsinchu, TW. FDA records list 15 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 15 510(k) clearances for Radiant Innovation Inc. between 2001 and 2024. The busiest year on record is 2010, with 3. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 1 |
| 2002 | 1 |
| 2003 | 1 |
| 2004 | 1 |
| 2005 | 1 |
| 2006 | 1 |
| 2007 | 1 |
| 2010 | 3 |
| 2011 | 1 |
| 2012 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K240648 | Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE) | FLL | Substantially Equivalent | |
| K163601 | RII Smart IR Thermometer | FLL | Substantially Equivalent | |
| K162083 | RII Multi-function Infrared Thermometer, Model TH52Z | FLL | Substantially Equivalent | |
| K121428 | NON-CONTACT CLINICAL THERMOMETER | FLL | Substantially Equivalent | |
| K111637 | INFRARED EAR THERMOMETER | FLL | Substantially Equivalent | |
| K103097 | INFRARED EAR THERMOMETER | FLL | Substantially Equivalent | |
| K102187 | RII INFRARED EAR THERMOMETER, | FLL | Substantially Equivalent | |
| K101253 | RII INFRARED EAR THERMOMETER, MODEL: TH60N | FLL | Substantially Equivalent | |
| K070976 | RII INFRARED EAR THERMOMETER, MODEL TH01BN | FLL | Substantially Equivalent | |
| K063185 | RII INFRARED EAR THERMOMETER, MODELS TH5XY SERIES | FLL | Substantially Equivalent | |
| K051269 | RII INFRARED EAR THERMOMETER, MODELS TH00XY SERIES | FLL | Substantially Equivalent | |
| K040377 | RII INFRARED EAR THERMOMETER, MODELS THXXN SERIES | FLL | Substantially Equivalent | |
| K030324 | RADIANT INNOVATION INC. INFRARED EAR THERMOMETER, MODELS TH1 SERIES | FLL | Substantially Equivalent | |
| K020504 | INFRARED EAR THERMOMETER, MODELS TH88 SERIES | FLL | Substantially Equivalent | |
| K011059 | INFARED EAR THERMOMETER, MODEL TH8 SERIES | FLL | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9710548 | 3003515005 | RADIANT INNOVATION INC. | 1F, NO.3, INDUSTRIAL E. 9TH RD, HSINCHU Hsinchu(County) 30075 TW | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain