Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Best Theratronics 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) |
|---|---|---|---|---|---|
| K181737 | Raycell MK1 | Best Theratronics Limited | 2019-01-02 | 184 | 0 |
| K161324 | Raycell Mk2 | Best Theratronics Limited | 2016-08-12 | 93 | 0 |
| K150191 | GammaBeam 500 | Best Theratronics Limited | 2015-04-17 | 79 | 0 |
| K142219 | GammaBeam 100 | Best Theratronics Limited | 2014-11-13 | 93 | 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