Data / Medical devices / South Korea / JLK, Inc.
JLK, Inc.: FDA-registered device maker in Gangnam Seoul, South Korea, 8 510(k) clearances
JLK, Inc. is registered with the FDA (registration 3038177848) in Gangnam Seoul, South Korea. It lists 4 device types. The FDA files 8 510(k) clearances under its listings, the newest dated March 24, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3038177848
- Address
- Teheranro33-Gil 5/11f, Gangnam Seoul, South Korea, 06141
- Owner or operator
- JLK Inc (10092928)
- Roles
- Manufacturer
- First device listed
- March 7, 2025
- Registered through
- 2026
- Brand names listed
- FASTRO, JLK-AILink, JLK-CTP, JLK-ICH, JLK-LVO, JLK-NCCT, JLK-PWI, JLK-SDH and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Manufacturer | accessdata.fda.gov |
| Radiological Computer-Assisted Triage And Notification Software | QAS | 2 | Manufacturer | accessdata.fda.gov |
| System, Digital Image Communications, Radiological | LMD | 1 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 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 |
|---|---|---|---|---|---|---|
| March 24, 2026 | K252421 | JLK-NCCT | QAS | Substantially Equivalent | JLK, Inc. | accessdata.fda.gov |
| March 3, 2025 | K243611 | JLK-SDH | QAS | Substantially Equivalent | JLK, Inc. | accessdata.fda.gov |
| February 25, 2025 | K250348 | JLK-AILink | LLZ | Substantially Equivalent | JLK, Inc. | accessdata.fda.gov |
| January 3, 2025 | K243363 | JLK-ICH | QAS | Substantially Equivalent | JLK, Inc. | accessdata.fda.gov |
| November 4, 2024 | K242709 | JLK-PWI | LLZ | Substantially Equivalent | JLK, Inc. | accessdata.fda.gov |
| October 16, 2024 | K242556 | JLK-CTP | LLZ | Substantially Equivalent | JLK, Inc. | accessdata.fda.gov |
| September 27, 2024 | K241480 | JBS-LVO | QAS | Substantially Equivalent | JLK, Inc. | accessdata.fda.gov |
| June 21, 2024 | K233196 | Medihub Prostate | QIH | Substantially Equivalent | JLK, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Digital Image Communications, Radiological
- All makers of Radiological Computer-Assisted Triage And Notification Software
- All makers of System, Image Processing, Radiological
- All makers of Automated Radiological Image Processing Software
Updated March 24, 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.