Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Skanray Technologies Limited · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251893 | SKAN C PULSAR | Skanray Technologies Limited | 2025-12-16 | 179 | 0 |
| K231761 | PodSKAN HF Diagnostic X-ray System | Skanray Technologies Limited | 2023-10-27 | 133 | 0 |
| K220518 | SKANRAD 400 | Skanray Technologies Limited | 2022-04-01 | 37 | 0 |
| K212940 | Skanmobile, Skanmobile-Dr | Skanray Technologies Limited | 2022-03-04 | 170 | 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