K241665
- 510(k) number
- K241665
- Device name
- Omni Legend
- Applicant
- Ge Medical Systems Israel, Functional Imaging IL
- Product code
- KPS — System, Tomography, Computed, Emission
- Decision date
- 2024-08-08
- Date received
- 2024-06-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.6 MB · U.S. public domain
Also available from FDA: K241665.pdf
Official FDA record: K241665
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.