K233247
- 510(k) number
- K233247
- Device name
- Heuron ICH
- Applicant
- Heuron Co., Ltd. KR
- Product code
- QAS — Radiological Computer-Assisted Triage And Notificati
- Decision date
- 2024-05-15
- Date received
- 2023-09-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K233247.pdf
Official FDA record: K233247
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.