Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Anatomage, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
65 daysmedian FDA review time
244 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K181926 | InVivo Web Viewer | Anatomage, Inc. | 2018-09-21 | 65 | 0 |
| K161270 | CephSimulation | Anatomage, Inc. | 2017-01-04 | 244 | 0 |
| K150976 | Collage | Anatomage, Inc. | 2015-06-04 | 52 | 0 |
| K140093 | TABLE | Anatomage, Inc. | 2014-03-07 | 52 | 0 |
| K123519 | INVIVO DENTAL | Anatomage, Inc. | 2013-02-01 | 78 | 0 |
| K070803 | INVIVODENTAL | Anatomage, Inc. | 2007-04-06 | 14 | 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