Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Echopixel, Inc. — 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) |
|---|---|---|---|---|---|
| K201365 | True 3D Viewer | Echopixel, Inc. | 2020-07-17 | 56 | 0 |
| K193149 | True 3D Viewer Software | Echopixel, Inc. | 2019-12-27 | 44 | 0 |
| K170167 | True 3D Viewer Software | Echopixel, Inc. | 2017-03-03 | 43 | 1 |
| K142107 | ECHO TRUE 3D VIEWER | Echopixel, Inc. | 2015-01-21 | 173 | 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