Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Orthoscan, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
41 daysmedian FDA review time
213 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K213113 | Orthoscan Tau Mini C-Arm | Orthoscan, Inc. | 2021-10-21 | 24 | 0 |
| K183220 | OrthoScan TAU Mini C-Arm | Orthoscan, Inc. | 2019-06-21 | 213 | 0 |
| K133174 | ORTHOSCAN FD MINI C-ARM | Orthoscan, Inc. | 2014-03-28 | 162 | 0 |
| K113708 | ORTHOSCAN MOBILE DI MINI C-ARM | Orthoscan, Inc. | 2012-01-05 | 20 | 0 |
| K051754 | ORTHOSCAN, ORTHOSCAN HD | Orthoscan, Inc. | 2005-08-09 | 41 | 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