Data / Medical devices / South Korea / Radisen Co Ltd
Radisen Co Ltd: FDA-registered device maker in Anyang Gyeonggi, South Korea, 3 510(k) clearances
Radisen Co Ltd is registered with the FDA (registration 3017004860) in Anyang Gyeonggi, South Korea. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated August 19, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017004860
- Address
- B-602, Hifield Building, 66, Beolmal-ro, Dongan-gu, Anyang Gyeonggi, South Korea, 14058
- Owner or operator
- Radisen Co Ltd (10079944)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- January 5, 2021
- Registered through
- 2026
- Brand names listed
- AXIR-CX, PEDRA-1417MC Digital Flat Panel X-ray Detector, PEDRA-1417MG Digital Flat Panel X-ray Detector, PEDRA-17F Digital Flat Panel X-ray Detector, PEDRA-17FC Digital Flat Panel X-ray Detector, PEDRA-17FG Digital Flat Panel X-ray Detector
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| August 19, 2022 | K213520 | AXIR-CX | LLZ | Substantially Equivalent | Radisen Co., Ltd. | accessdata.fda.gov |
| May 13, 2022 | K221144 | PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG | MQB | Substantially Equivalent | Radisen Co., Ltd. | accessdata.fda.gov |
| June 13, 2018 | K180989 | PEDRA-17F Digital Flat Panel X-ray Detector | MQB | Substantially Equivalent | Radisen, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Solid State X-Ray Imager (Flat Panel/Digital Imager)
- All makers of System, Image Processing, Radiological
Updated August 19, 2022. 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.