Data / Medical devices / South Korea / Fcu Co., Ltd.
Fcu Co., Ltd.: FDA-registered device maker in Daejeon, South Korea, 2 510(k) clearances
Fcu Co., Ltd. is registered with the FDA (registration 3017955833) in Daejeon, South Korea. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 26, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017955833
- Address
- 2F, 62-4, Techno 1-ro, Yuseong-gu, Daejeon, South Korea, 34014
- Owner or operator
- FCU Co., Ltd. (10082644)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- August 31, 2021
- Registered through
- 2026
- Brand names listed
- AcuViz Pocket, SC1, Site-Rite 8 Probe, SiteRite 9 Cue Probe (SKU 9770803)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | 2 | Manufacturer | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 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 |
|---|---|---|---|---|---|---|
| June 26, 2024 | K233579 | SC1 Handheld Ultrasound Imaging system (Model: SC1) | IYO | Substantially Equivalent | Fcu Co., Ltd. | accessdata.fda.gov |
| July 23, 2021 | K210468 | SC1 Handheld Ultrasound Imaging System (Model: SC1) | IYO | Substantially Equivalent | Fcu Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of System, Imaging, Pulsed Doppler, Ultrasonic
Updated June 26, 2024. 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.