K243611
- 510(k) number
- K243611
- Device name
- JLK-SDH
- Applicant
- JLK, Inc. KR
- Product code
- QAS — Radiological Computer-Assisted Triage And Notificati
- Decision date
- 2025-03-03
- Date received
- 2024-11-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K243611.pdf
Official FDA record: K243611
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.