K251153
- 510(k) number
- K251153
- Device name
- Aurora
- Applicant
- Ge Medical Systems Israel IL
- Product code
- KPS — System, Tomography, Computed, Emission
- Decision date
- 2025-06-12
- Date received
- 2025-04-14
- 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: K251153.pdf
Official FDA record: K251153
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.