K232569
- 510(k) number
- K232569
- Device name
- CAREMIBRAIN
- Applicant
- General Equipment For Medical Imaging, S.A. ES
- Product code
- KPS — System, Tomography, Computed, Emission
- Decision date
- 2023-09-21
- Date received
- 2023-08-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K232569.pdf
Official FDA record: K232569
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.