Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nano-X Imaging , Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
113 daysmedian FDA review time
214 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252649 | TAP2D | Nano-X Imaging , Ltd. | 2026-02-02 | 165 | 0 |
| K250850 | Nanox.ARC X | Nano-X Imaging , Ltd. | 2025-04-16 | 27 | 0 |
| K242395 | Nanox.ARC | Nano-X Imaging , Ltd. | 2024-12-04 | 113 | 0 |
| K222934 | Nanox.ARC | Nano-X Imaging , Ltd. | 2023-04-28 | 214 | 0 |
| K203782 | Nanox Cart X-ray System | Nano-X Imaging , Ltd. | 2021-04-01 | 94 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda