Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Image Data Corp. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
139 daysmedian FDA review time
264 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K931186 | PHOTOPHONE MULTIVIEW | Image Data Corp. | 1993-11-22 | 258 | 0 |
| K931292 | MULTIVIEW FOR WINDOWS | Image Data Corp. | 1993-07-29 | 139 | 0 |
| K931060 | STATVIEW | Image Data Corp. | 1993-05-20 | 80 | 0 |
| K922267 | PHOTOPHONE(R) MULTI VIEW(TM) | Image Data Corp. | 1993-02-02 | 264 | 0 |
| K921527 | STATVIEW | Image Data Corp. | 1992-06-24 | 82 | 0 |
| K896223 | PHOTOPHONE | Image Data Corp. | 1990-02-12 | 105 | 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