Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Enhanced Imaging Technologies, 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) |
|---|---|---|---|---|---|
| K912896 | DIGISTORE 2100 | Enhanced Imaging Technologies, Inc. | 1991-08-26 | 56 | 0 |
| K904519 | AGFA DIAGNOSTIC CENTER (ADC) | Enhanced Imaging Technologies, Inc. | 1991-06-21 | 261 | 0 |
| K903238 | AFGA VIDEO IMAGER, VARIOUS MODELS | Enhanced Imaging Technologies, Inc. | 1990-11-02 | 107 | 0 |
| K891924 | SCOPIX LASER IMAGER | Enhanced Imaging Technologies, Inc. | 1989-05-18 | 52 | 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