Data / Medical devices / South Korea / Astel.inc
Astel.inc: FDA-registered device maker in Yuseong-gu Daejeon, South Korea, 1 510(k) clearance
Astel.inc is registered with the FDA (registration 3022131441) in Yuseong-gu Daejeon, South Korea. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated August 25, 2021. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3022131441
- Address
- Gajeongbuk-ro 26-79, Yuseong-gu Daejeon, South Korea, 34113
- Owner or operator
- ASTEL Inc (10084667)
- Roles
- Manufacturer
- First device listed
- March 20, 2022
- Registered through
- 2027
- Brand names listed
- RFA-1717DI
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 |
|---|---|---|---|---|---|---|
| August 25, 2021 | K212051 | RFA-1717DIG, RFA-1717DIC | MQB | Substantially Equivalent | Astel, Inc. | accessdata.fda.gov |
Compare with other makers
Updated August 25, 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.