K250850
- 510(k) number
- K250850
- Device name
- Nanox.ARC X
- Applicant
- Nano-X Imaging , Ltd. IL
- Product code
- IZF — System, X-Ray, Tomographic
- Decision date
- 2025-04-16
- Date received
- 2025-03-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K250850.pdf
Official FDA record: K250850
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.