K250348
- 510(k) number
- K250348
- Device name
- JLK-AILink
- Applicant
- JLK, Inc. KR
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2025-02-25
- Date received
- 2025-02-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 3.2 MB · U.S. public domain
Also available from FDA: K250348.pdf
Official FDA record: K250348
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.