Data / Medical devices / South Korea / ECOTRON Co., Ltd.
ECOTRON Co., Ltd.: FDA-registered device maker in Seoul, South Korea, 4 510(k) clearances
ECOTRON Co., Ltd. is registered with the FDA (registration 3011491794) in Seoul, South Korea. It lists 9 device types. The FDA files 4 510(k) clearances under its listings, the newest dated June 27, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011491794
- Address
- 501, 502, 504, 505, 506 Ho, Hanshin IT Tower II, 47, Digital-ro 9-gil, Geumcheon-Gu, Seoul, South Korea, 08511
- Owner or operator
- ECOTRON Co., Ltd. (10049861)
- Roles
- Manufacturer
- First device listed
- August 16, 2015
- Registered through
- 2026
- Brand names listed
- Anyview-240DR, Anyview-320DR, Anyview-500DR, EPX Series Mobile X-ray System EPX-F1600, EPX-F2400, EPX-F2800, EPX-F3200, EPX-F4000, EPX-F5000, EXS-BK10, EXS-FC10, EXS-FM10, EXS-TA10 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Generator, High-Voltage, X-Ray, Diagnostic | IZO | 1 | Manufacturer | accessdata.fda.gov |
| Image-Intensified Fluoroscopic X-Ray System, Mobile | OXO | 2 | Manufacturer | accessdata.fda.gov |
| Interventional Fluoroscopic X-Ray System | OWB | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Film Marking, Radiographic | JAC | 1 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Mobile | IZL | 2 | Manufacturer | accessdata.fda.gov |
| Table, Radiologic | KXJ | 2 | Manufacturer | accessdata.fda.gov |
| Tube Mount, X-Ray, Diagnostic | IYB | 1 | Manufacturer | accessdata.fda.gov |
| Unit, X-Ray, Extraoral With Timer | EHD | 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 27, 2022 | K221233 | DT-703 | EHD | Substantially Equivalent | Ecotron Co., Ltd. | accessdata.fda.gov |
| March 23, 2018 | K180473 | ANYVIEW DR SERIES FPD Fluoroscopic Mobile C-arm ANYVIEW-240DR, ANYVIEW-320DR, ANYVIEW-500DR | OWB | Substantially Equivalent | Ecotron Co., Ltd. | accessdata.fda.gov |
| October 14, 2016 | K160279 | ANYVIEW-500R Fluoroscopic Mobile X-Ray System | OWB | Substantially Equivalent | Ecotron Co., Ltd. | accessdata.fda.gov |
| July 24, 2015 | K151038 | EPX-Series Mobile X-ray System | IZL | Substantially Equivalent | Ecotron Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of System, X-Ray, Fluoroscopic, Image-Intensified
- All makers of Image-Intensified Fluoroscopic X-Ray System, Mobile
- All makers of Interventional Fluoroscopic X-Ray System
- All makers of System, X-Ray, Film Marking, Radiographic
- All makers of Table, Radiologic
- All makers of Tube Mount, X-Ray, Diagnostic
Updated June 27, 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.