K243605
- 510(k) number
- K243605
- Device name
- Aurora
- Applicant
- Ge Medical Systems Israel, Functional Imaging IL
- Product code
- KPS — System, Tomography, Computed, Emission
- Decision date
- 2025-01-17
- Date received
- 2024-11-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K243605.pdf
Official FDA record: K243605
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.