Data / Medical devices / Taiwan / Innocare Optoelectronics Corp.
Innocare Optoelectronics Corp.: FDA-registered device maker in Tainan, Taiwan, 6 510(k) clearances
Innocare Optoelectronics Corp. is registered with the FDA (registration 3015531968) in Tainan, Taiwan. It lists 1 device type. The FDA files 6 510(k) clearances under its listings, the newest dated July 22, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015531968
- Address
- Rm. B, No. 2, Sec. 2, Huanxi Rd., Southern Taiwan Science Park, Xinshi Dist., Tainan City 741, Taiwan, R.O.C., Tainan, Taiwan, 741
- Owner or operator
- InnoCare Optoelectronics Corp. (10060738)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- June 18, 2019
- Registered through
- 2026
- Brand names listed
- ENDURO DR, Enduro DR, REMEX RD, RXSensor, Reveal 35C, Yushan Flat Panel Detector (flexible), Yushan Flat Panel Detector with DROC, Yushan Flat Panel Detector with Xresta+iOS and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | 2 | Contract manufacturer, Manufacturer | 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 |
|---|---|---|---|---|---|---|
| July 22, 2025 | K250211 | Yushan X-Ray Flat Panel Detector | MQB | Substantially Equivalent | Innocare Optoelectronics Corp. | accessdata.fda.gov |
| December 19, 2024 | K243171 | Yushan X-Ray Flat Panel Detector | MQB | Substantially Equivalent | Innocare Optoelectronics Corp. | accessdata.fda.gov |
| April 14, 2022 | K220510 | Yushan X-Ray Flat Panel Detector with DROC | MQB | Substantially Equivalent | Innocare Optoelectronics Corp. | accessdata.fda.gov |
| April 21, 2021 | K210988 | Yushan X-Ray Flat Panel Detector with DROC | MQB | Substantially Equivalent | Innocare Optoelectronics Corp. | accessdata.fda.gov |
| October 11, 2020 | K201528 | Yushan X-Ray Flat Panel Detector with DROC | MQB | Substantially Equivalent | Innocare Optoelectronics Corp. | accessdata.fda.gov |
| August 29, 2019 | K191939 | Yushan X-Ray Flat Panel Detector | MQB | Substantially Equivalent | Innocare Optoelectronics Corp. | accessdata.fda.gov |
Compare with other makers
Updated July 22, 2025. 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.