K252421

JLK-NCCT

510(k) number
K252421
Device name
JLK-NCCT
Applicant
JLK, Inc. KR
Product code
QAS — Radiological Computer-Assisted Triage And Notificati
Decision date
2026-03-24
Date received
2025-08-01
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Radiology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain

Also available from FDA: K252421.pdf

Official FDA record: K252421
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.