K230370
- 510(k) number
- K230370
- Device name
- SpotLight/SpotLight Duo (with DLIR option)
- Applicant
- Arineta , Ltd. IL
- Product code
- JAK — System, X-Ray, Tomography, Computed
- Decision date
- 2023-10-13
- Date received
- 2023-02-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K230370.pdf
Official FDA record: K230370
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.