K231576
- 510(k) number
- K231576
- Device name
- cNeuro cPET
- Applicant
- Combinostics OY FI
- Product code
- KPS — System, Tomography, Computed, Emission
- Decision date
- 2023-09-14
- Date received
- 2023-05-31
- 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: K231576.pdf
Official FDA record: K231576
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.