Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Fisher Imaging Corp. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K952456 | IMAGE INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM | Fisher Imaging Corp. | 1995-06-16 | 22 | 0 |
| K870783 | BPA CARDIOVASCULAR PRESSURE AMPLIFIER | Fisher Imaging Corp. | 1987-04-27 | 60 | 0 |
| K853652 | BERS-400A ELECTROPHYSIOLOGICAL AMPLIFIERS & INPUT | Fisher Imaging Corp. | 1986-01-16 | 135 | 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