K233080
- 510(k) number
- K233080
- Device name
- HealthFLD
- Applicant
- Nano-X AI , Ltd. IL
- Product code
- JAK — System, X-Ray, Tomography, Computed
- Decision date
- 2024-02-08
- Date received
- 2023-09-26
- 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: K233080.pdf
Official FDA record: K233080
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.