Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Helax AB — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K993766 | HELAX-TMS V 5.0 RADIATION THERAPY TREATMENT PLANNING SYSTEM | Helax AB | 1999-12-08 | 30 | 0 |
| K982857 | HELAX-IMCON, VERSION 1.0 | Helax AB | 1998-11-04 | 83 | 0 |
| K972617 | HELAX-VISIR | Helax AB | 1997-10-01 | 84 | 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