FDA applicant
Nano-X Imaging, Ltd.
FDA records 5 decisions for Nano-X Imaging, Ltd. (Petah Tikva, IL) from 2021 to 2026: 5 510(k) clearances. Most are in product codes IZF (System, X-Ray, Tomographic) and IZL (System, X-Ray, Mobile). Its devices cite 5 predicates, 3 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Nano-X Imaging, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2021.
Planning a device like Nano-X Imaging, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report