K232231
- 510(k) number
- K232231
- Device name
- QP-Brain®
- Applicant
- Quibim S.L. ES
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2023-12-13
- Date received
- 2023-07-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K232231.pdf
Official FDA record: K232231
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.