Nano-X Imaging , Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Nano-X Imaging , Ltd.” (first 2021, latest 2026), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 113 days. Since 2017 the median was 113 days, against 88 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2021 | 1 | 94 |
| 2022 | 0 | — |
| 2023 | 1 | 214 |
| 2024 | 1 | 113 |
| 2025 | 1 | 27 |
| 2026 | 1 | 165 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Nano-X Imaging , Ltd. took a median 113 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 88 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IZF | System, X-Ray, Tomographic | 4 | 4 |
| IZL | System, X-Ray, Mobile | 1 | 1 |
Review panels
- Radiology (5)
Most recent Nano-X Imaging , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252649 | TAP2D | IZF | 2026-02-02 | 165 |
| K250850 | Nanox.ARC X | IZF | 2025-04-16 | 27 |
| K242395 | Nanox.ARC | IZF | 2024-12-04 | 113 |
| K222934 | Nanox.ARC | IZF | 2023-04-28 | 214 |
| K203782 | Nanox Cart X-ray System | IZL | 2021-04-01 | 94 |
Recalls
openFDA lists no recalls under a recalling firm named Nano-X Imaging , Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
SEC filings
Nano-X Imaging Ltd. (NNOX): EDGAR filings, CIK 1795251. An SEC registrant with the same name, matched by name only.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Nano-X AI , Ltd. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Nano-X Imaging , Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Nano-X Imaging , Ltd.” (first 2021, latest 2026), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Nano-X Imaging , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nano-X Imaging , Ltd. is 113 days. Since 2017: 113 days, versus 88 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Nano-X Imaging , Ltd.?
The most frequent FDA product codes under this applicant name are IZF (System, X-Ray, Tomographic, 4); IZL (System, X-Ray, Mobile, 1).
Next steps
- See all 5 Nano-X Imaging , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code IZF, Nano-X Imaging , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.