Data / Medical devices / South Korea / Poskom Co., Ltd
Poskom Co., Ltd: FDA-registered device maker in Goyang-si Gyeonggi, South Korea, 6 510(k) clearances
Poskom Co., Ltd is registered with the FDA (registration 3005246977) in Goyang-si Gyeonggi, South Korea. It lists 2 device types. The FDA files 6 510(k) clearances under its listings, the newest dated February 23, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005246977
- Address
- POSKOM Tower, 227, Sowon-ro, Deogyang-gu, Goyang-si Gyeonggi, South Korea, 10534
- Owner or operator
- POSKOM CO., LTD (9053091)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer
- First device listed
- May 13, 2008
- Registered through
- 2026
- Brand names listed
- AirRay, AirRay-20H, AirRay-20HL, AirRay-20HLW, AirRay-20HW, AirRay-mini, AirRay-mini 80A, AirRay-mini 80F and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, X-Ray, Mobile | IZL | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Unit, X-Ray, Extraoral With Timer | EHD | 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 |
|---|---|---|---|---|---|---|
| February 23, 2026 | K253244 | AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini) | IZL | Substantially Equivalent | Poskom Co., Ltd. | accessdata.fda.gov |
| December 19, 2025 | K250976 | Airbile-100 | IZL | Substantially Equivalent | Poskom Co., Ltd. | accessdata.fda.gov |
| December 20, 2022 | K222896 | AirRay | IZL | Substantially Equivalent | Poskom Co., Ltd. | accessdata.fda.gov |
| July 31, 2013 | K132041 | REXTAR X | EHD | Substantially Equivalent | Meta Biomed, Inc. | accessdata.fda.gov |
| February 2, 2004 | K032628 | PORTABLE X-RAY UNIT, MODELS PXP-15/20/40HF | IZL | Substantially Equivalent | United Radiology Systems, Inc. | accessdata.fda.gov |
| September 15, 2000 | K002685 | CORDLESS COMPACT MOBILE X-RAY SYSTEM | IZL | Substantially Equivalent | Medison Radiology Systems, Inc. | accessdata.fda.gov |
Compare with other makers
Updated February 23, 2026. 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.