Data / Medical devices / South Korea / PixxGen Corporation
PixxGen Corporation: FDA-registered device maker in Anyang-si Gyeonggi, South Korea, 3 510(k) clearances
PixxGen Corporation is registered with the FDA (registration 3008304180) in Anyang-si Gyeonggi, South Korea. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated June 4, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008304180
- FEI number
- 3008164200
- Address
- 5F Smart Bay 123, Beolmal-ro, Dongan-gu, Anyang-si Gyeonggi, South Korea, 14056
- Owner or operator
- PixxGen Corporation (10035114)
- Roles
- Manufacturer
- First device listed
- December 5, 2018
- Registered through
- 2026
- Brand names listed
- PIXX1717;PIXX1417;PIXX1212, PIXX2430, Prudent 1717, Prudent 1417, Prudent 1212
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | 2 | 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 |
|---|---|---|---|---|---|---|
| June 4, 2021 | K211108 | Prudent 1717, Prudent 1417, Prudent 1212 | MQB | Substantially Equivalent | Pixxgen Corporation | accessdata.fda.gov |
| April 4, 2019 | K190691 | Pixx2430 Digital Diagnostic X-Ray Receptor Panel | MQB | Substantially Equivalent | Pixxgen Corporation | accessdata.fda.gov |
| October 4, 2018 | K182533 | PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels | MQB | Substantially Equivalent | Pixxgen Corporation | accessdata.fda.gov |
Compare with other makers
Updated June 4, 2021. 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.