Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
O Tech, 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) |
|---|---|---|---|---|---|
| K991643 | IDS4 V3.2 IMAGE DISPLAY SYSTEM | O Tech, Inc. | 1999-06-08 | 26 | 0 |
| K973463 | OLICON IMAGING SYSTEMS, INC. ARCHIVE SYSTEMS, NT ARCHIVE, 02 | O Tech, Inc. | 1997-12-02 | 81 | 0 |
| K971368 | IDS4 IMAGE DISPLAY SYSTEM SERIES | O Tech, Inc. | 1997-06-26 | 73 | 0 |
| K971451 | WISE IMAGE MANAGEMENT SYSTEM | O Tech, Inc. | 1997-06-26 | 66 | 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