K252649
- 510(k) number
- K252649
- Device name
- TAP2D
- Applicant
- Nano-X Imaging , Ltd. IL
- Product code
- IZF — System, X-Ray, Tomographic
- Decision date
- 2026-02-02
- Date received
- 2025-08-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K252649.pdf
Official FDA record: K252649
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.