K242395
- 510(k) number
- K242395
- Device name
- Nanox.ARC
- Applicant
- Nano-X Imaging , Ltd. IL
- Product code
- IZF — System, X-Ray, Tomographic
- Decision date
- 2024-12-04
- Date received
- 2024-08-13
- 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: K242395.pdf
Official FDA record: K242395
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.