K232363
- 510(k) number
- K232363
- Device name
- Viz HDS, Viz Volume Plus, Viz ICH+
- Applicant
- Viz. Ai, Inc. CA · US
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2024-02-05
- Date received
- 2023-08-07
- 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: K232363.pdf
Official FDA record: K232363
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.