K243363
- 510(k) number
- K243363
- Device name
- JLK-ICH
- Applicant
- JLK, Inc. KR
- Product code
- QAS — Radiological Computer-Assisted Triage And Notificati
- Decision date
- 2025-01-03
- Date received
- 2024-10-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K243363.pdf
Official FDA record: K243363
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.