K240827
- 510(k) number
- K240827
- Device name
- SET-5002
- Applicant
- Shimadzu Corporation Medical Systems Division JP
- Product code
- KPS — System, Tomography, Computed, Emission
- Decision date
- 2024-05-24
- Date received
- 2024-03-26
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K240827.pdf
Official FDA record: K240827
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.