K241200
- 510(k) number
- K241200
- Device name
- SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option
- Applicant
- Arineta , Ltd. IL
- Product code
- JAK — System, X-Ray, Tomography, Computed
- Decision date
- 2025-01-13
- Date received
- 2024-04-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K241200.pdf
Official FDA record: K241200
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.