K250170
- 510(k) number
- K250170
- Device name
- PHAROS
- Applicant
- Brightonix Imaging KR
- Product code
- KPS — System, Tomography, Computed, Emission
- Decision date
- 2025-08-15
- Date received
- 2025-01-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K250170.pdf
Official FDA record: K250170
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.