K231570
- 510(k) number
- K231570
- Device name
- StrokeViewer Perfusion
- Applicant
- Nico-Lab B.V. NL
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2023-12-14
- Date received
- 2023-05-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K231570.pdf
Official FDA record: K231570
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.