K252477
- 510(k) number
- K252477
- Device name
- Hybrid Viewer (00859873006240)
- Applicant
- Hermes Medical Solutions AB SE
- Product code
- KPS — System, Tomography, Computed, Emission
- Decision date
- 2025-09-09
- Date received
- 2025-08-07
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K252477.pdf
Official FDA record: K252477
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.