Eastman Kodak Company: FDA filings under this applicant name
FDA lists 238 510(k) clearances under the applicant name “Eastman Kodak Company” (first 1977, latest 2006), across 73 product codes in 7 review panels. Median 510(k) review time under this name: 48 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IXW | Processor, Radiographic-Film, Automatic | 31 | 31 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 18 | 18 |
| IWZ | Film, Radiographic | 17 | 17 |
| LMC | Camera, Multi Format, Radiological | 14 | 14 |
| IXA | Cassette, Radiographic Film | 13 | 13 |
| LLZ | System, Image Processing, Radiological | 13 | 13 |
| EAM | Screen, Intensifying, Radiographic | 7 | 7 |
| LMD | System, Digital Image Communications, Radiological | 7 | 7 |
| JAC | System, X-Ray, Film Marking, Radiographic | 6 | 6 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 6 | 6 |
Plus 63 more product codes.
Review panels
- Radiology (129)
- Clinical Chemistry (80)
- Clinical Toxicology (10)
- Microbiology (8)
- Cardiovascular (3)
- Hematology (1)
- General and Plastic Surgery (1)
Most recent Eastman Kodak Company 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K060550 | KODAK DIRECTVIEW DR 3000 SYSTEM 64KW/80KW GENERATORS, MODELS 6551345, 6551386 | KPR | 2006-03-31 | 29 |
| K060137 | KODAK ECLIPSE IMAGE PROCESSING SOFTWARE | MQB | 2006-03-16 | 56 |
| K060079 | KODAK MODEL CR-7400 DIGITAL RADIOGRAPHY SYSTEM | MUH | 2006-02-08 | 29 |
| K060055 | KODAK PACS | LLZ | 2006-02-07 | 29 |
| K053347 | KODAK CARESTREAM PACS | LLZ | 2006-01-04 | 33 |
| K051483 | KODAK DIRECTVIEW DR SYSTEM DETECTOR | MQB | 2005-06-21 | 15 |
| K051258 | KODAK DIRECTVIEW DR 7500 SYSTEM, MODEL 8791345 | KPR | 2005-06-01 | 16 |
| K042159 | KODAK COLOR MEDICAL IMAGER 1000 | LMC | 2004-09-24 | 45 |
| K042158 | KODAK MEDICAL IMAGER 300 | LMC | 2004-09-24 | 45 |
| K040378 | KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253 | IXA | 2004-05-24 | 97 |
228 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Eastman Kodak Company.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Eastman Kodak Company?
FDA lists 238 510(k) clearances under the applicant name “Eastman Kodak Company” (first 1977, latest 2006), across 73 product codes in 7 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Eastman Kodak Company?
The median time from FDA receipt to decision across 510(k)s cleared under the name Eastman Kodak Company is 48 days.
Which FDA product codes appear under Eastman Kodak Company?
The most frequent FDA product codes under this applicant name are IXW (Processor, Radiographic-Film, Automatic, 31); JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use, 18); IWZ (Film, Radiographic, 17).
Next steps
- See all 238 Eastman Kodak Company clearances with predicates and recalls
- Run predicate analysis for product code IXW, Eastman Kodak Company's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.