Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
De Götzen S.R.L. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
239 daysmedian FDA review time
303 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231055 | x-mind dc (under trademark Acteon), Owandy-RX DC (under trad | De Götzen S.R.L. | 2023-12-28 | 259 | 0 |
| K203374 | X-MIND prime (under trade mark Acteon), I-MAX (under trade m | De Götzen S.R.L. | 2021-02-05 | 81 | 0 |
| K201382 | X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under tr | De Gotzen S.R.L. | 2020-11-18 | 176 | 0 |
| K191719 | X-MIND Trium | De Gotzen S.R.L. | 2020-02-20 | 239 | 0 |
| K192165 | Acteon Imaging Suite | De Gotzen S.R.L. | 2020-02-11 | 186 | 0 |
| K160166 | X-MIND trium | De Gotzen S.R.L. | 2016-11-15 | 293 | 0 |
| K132378 | X-MIND UNITY | De Gotzen S.R.L. | 2014-05-30 | 303 | 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