Data / Medical devices / South Korea / Hutom Inc.
Hutom Inc.: FDA-registered device maker in Seoul, South Korea, 1 510(k) clearance
Hutom Inc. is registered with the FDA (registration 3045817397) in Seoul, South Korea. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated July 12, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3045817397
- Address
- 6F, 279, Dongmak-ro, Mapo-gu, Seoul, South Korea, 04155
- Owner or operator
- Hutom Inc. (10095810)
- Roles
- Manufacturer
- First device listed
- May 4, 2026
- Registered through
- 2026
- Brand names listed
- RUS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 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 |
|---|---|---|---|---|---|---|
| July 12, 2024 | K233457 | RUS | QIH | Substantially Equivalent | Hutom, Inc. | accessdata.fda.gov |
Compare with other makers
Updated July 12, 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.