Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Digivision, 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) |
|---|---|---|---|---|---|
| K962260 | REAL-TIME VIDEO CONTRAST ENHANCER | Digivision, Inc. | 1996-09-09 | 89 | 0 |
| K895320 | FLUOROVISION HR 2000 HIGH RESOLUTION IMAGE ENHANCE | Digivision, Inc. | 1989-11-01 | 64 | 0 |
| K873646 | DIGIVIEWER | Digivision, Inc. | 1987-10-08 | 30 | 0 |
| K864584 | FLUOROVISION CONTRAST ENHANCER | Digivision, Inc. | 1986-12-29 | 39 | 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