K243689
- 510(k) number
- K243689
- Device name
- AVIEW
- Applicant
- Coreline Soft Co., Ltd. KR
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2025-03-19
- Date received
- 2024-11-29
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K243689.pdf
Official FDA record: K243689
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.