Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Skanray Technologies Private 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) |
|---|---|---|---|---|---|
| K170946 | Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobi | Skanray Technologies Private Limited | 2017-11-24 | 239 | 0 |
| K170967 | Intraskan DC Plus | Skanray Technologies Private Limited | 2017-06-08 | 69 | 0 |
| K152831 | Spot Skan | Skanray Technologies Private Limited | 2016-02-23 | 147 | 0 |
| K151512 | Star 60 | Skanray Technologies Private Limited | 2016-02-14 | 255 | 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