Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Elekta Oncology Systems, Ltd. · 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) |
|---|---|---|---|---|---|
| K032996 | ELEKTA SYNERGY SYSTEM | Elekta Oncology Systems, Ltd. | 2003-10-23 | 28 | 3 |
| K012289 | MODIFICATION TO: VIEWGT ELECTRONIC PORTAL IMAGING DEVICE (EP | Elekta Oncology Systems, Ltd. | 2001-08-14 | 25 | 0 |
| K982713 | RT DESKTOP | Elekta Oncology Systems, Ltd. | 1998-11-02 | 90 | 3 |
| K981790 | IVIEW ELECTRONIC PORTAL IMAGING DEVICE (EPID) MODEL NUMBER I | Elekta Oncology Systems, Ltd. | 1998-08-07 | 79 | 1 |
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