K250354
- 510(k) number
- K250354
- Device name
- Viz Subdural+, Viz SUBDURAL PLUS
- Applicant
- Viz. Ai, Inc. NC · US
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2025-06-10
- Date received
- 2025-02-07
- 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: K250354.pdf
Official FDA record: K250354
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.