Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Kodak Health Imaging Systems, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
147 daysmedian FDA review time
195 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K961739 | KODAK DIGITAL SCIENCE MEDICAL MODALITY ACQUISITION UNIT | Kodak Health Imaging Systems, Inc. | 1996-11-14 | 195 | 0 |
| K961740 | KODAK DIGITAL SCIENCE MEDICAL PRINTER INTERFACE UNIT | Kodak Health Imaging Systems, Inc. | 1996-11-14 | 195 | 0 |
| K961768 | KODAK DIGITAL SCIENCE FILM DIGITIZER L7501/L7506 (WITH FILM | Kodak Health Imaging Systems, Inc. | 1996-08-22 | 106 | 0 |
| K960981 | KODAK DIGITAL SCIENCE(KDS) MEDICAL IMAGE AND INFORMATION LIB | Kodak Health Imaging Systems, Inc. | 1996-06-07 | 88 | 0 |
| K951807 | KODAK EKTASCAN TRIAD LASER PRINTER SYSTEM, PHOTON LASER PRIN | Kodak Health Imaging Systems, Inc. | 1995-09-13 | 147 | 0 |
| K951948 | KODAK XLS 8600 (PS) | Kodak Health Imaging Systems, Inc. | 1995-09-13 | 140 | 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