K250328
- 510(k) number
- K250328
- Device name
- UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program
- Applicant
- Canon Medical Systems Corporation JP
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2025-04-30
- Date received
- 2025-02-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K250328.pdf
Official FDA record: K250328
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.