JLK, Inc.
South KoreaFDA applicant, unverified FDA FEI 3038177848
- Devices
- 15
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What JLK, Inc. makes
JLK, Inc. manufactures medical imaging and diagnostic devices, including computed tomography perfusion (CTP) systems, artificial intelligence-assisted imaging software (AILink), and non-contrast CT (NCCT) solutions. Their portfolio also covers devices for detecting large vessel occlusions (LVO) in stroke patients, specialized imaging for prostate health, and perfusion-weighted imaging (PWI) tools for assessing tissue viability. Additional offerings include software for stroke detection (SDH) and intracranial hemorrhage (ICH) analysis.
All listed devices fall under Class II regulatory classification in the US and are recorded in the FDA’s 510(k) Premarket Notification database. The company operates under US jurisdiction, adhering to FDA requirements for these diagnostic and imaging products.
Catalogue
Search and filter all 15 devicesCompany details
- FDA FEI number
- 3038177848
- DUNS number
- 689695319
- Address
- Teheranro33-Gil 5/11f, Gangnam Seoul
Frequently asked questions
How many devices does JLK, Inc. have in the registry?
The registry currently lists 15 devices for JLK, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list JLK, Inc.'s devices?
Among its 15 most recently registered devices, JLK, Inc. has devices listed in FDA 510(k) (8 devices) and FDA GUDID (7 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do JLK, Inc.'s devices fall under?
Among its 15 most recently registered devices, the classes recorded for JLK, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from JLK, Inc. in the registry?
The most recently registered devices listed for JLK, Inc. include JLK-LVO V1.0.0.0, JLK-ICH V1.0.0.0, JLK-SDH V1.0.0.0 and JLK-AILINK V1.0.0.0.