K240712
- 510(k) number
- K240712
- Device name
- icobrain aria
- Applicant
- Icometrix NV BE
- Product code
- QBS — Radiological Computer Assisted Detection/Diagnosis S
- Decision date
- 2024-11-07
- Date received
- 2024-03-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.6 MB · U.S. public domain
Also available from FDA: K240712.pdf
Official FDA record: K240712
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.