Medical device manufacturer
Eastman Kodak Company
Eastman Kodak Company holds 238 FDA 510(k) clearances across 72 product codes. Median elapsed review time is 48 days. openFDA lists 3 recall records naming the company. FDA publishes it under 3 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 238
- Product codes
- 72
- Median review
- 48 days
- Recall records
- 3
How does FDA spell Eastman Kodak Company?
FDA publishes this company under 3 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| EASTMAN KODAK COMPANY | device/registrationlisting | normalised |
| Eastman Kodak Co | device/recall | normalised |
| Eastman Kodak Company | device/510k | normalised |
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does Eastman Kodak Company file in?
72 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| IXW | Processor, Radiographic-Film, Automatic | 31 | 49 days | |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 18 | 33 days | |
| IWZ | Film, Radiographic | 17 | 42 days | |
| LMC | Camera, Multi Format, Radiological | 14 | 45 days | |
| IXA | Cassette, Radiographic Film | 13 | 30 days | |
| LLZ | System, Image Processing, Radiological | 13 | 69 days | |
| EAM | Screen, Intensifying, Radiographic | 7 | 32 days | |
| LMD | System, Digital Image Communications, Radiological | 7 | 83 days | |
| JAC | System, X-Ray, Film Marking, Radiographic | 6 | 16 days | |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 6 | 49 days | |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 6 | 43 days | |
| LJC | Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) | 4 | 51 days | |
| LMB | Device, Digital Image Storage, Radiological | 4 | 85 days | |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 4 | 22 days | |
| CIG | Diazo Colorimetry, Bilirubin | 3 | 54 days | |
| KPR | System, X-Ray, Stationary | 3 | 29 days | |
| LMA | Digitizer, Image, Radiological | 3 | 106 days | |
| CEC | Radioimmunoassay, Free Thyroxine | 2 | 41 days | |
| CEK | Biuret (Colorimetric), Total Protein | 2 | 14 days | |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 2 | 57 days | |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 2 | 30 days | |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 2 | 16 days | |
| CHI | Lipase-Esterase, Enzymatic, Photometric, Lipase | 2 | 22 days | |
| CIX | Bromcresol Green Dye-Binding, Albumin | 2 | 14 days | |
| DIH | Colorimetry, Cholinesterase | 2 | 39 days |
Showing the 25 they file in most, of 72.
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Eastman Kodak Company had a recall?
openFDA lists 3 recall records naming this company across its whole history. A recall record covers one firm's corrective action and may span many device lots.
Z-0274-06TerminatedKPR
Potential weld defect in the Overhead Tube Support assembly which connects the tube assembly to the telescoping arm. This could cause the tube assembly to fall, injuring anyone near the unit.
Z-0817-05TerminatedIXJ
Screens may be affected with image artifacts
Z-0728-04TerminatedKPR
Defective component in overhead tube support balancer may cause the suspended load to fall.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Eastman Kodak Company cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K060550 | KODAK DIRECTVIEW DR 3000 SYSTEM 64KW/80KW GENERATORS, MODELS 6551345, 6551386 | KPR | 29 | |
| K060137 | KODAK ECLIPSE IMAGE PROCESSING SOFTWARE | MQB | 56 | |
| K060079 | KODAK MODEL CR-7400 DIGITAL RADIOGRAPHY SYSTEM | MUH | 29 | |
| K060055 | KODAK PACS | LLZ | 29 | |
| K053347 | KODAK CARESTREAM PACS | LLZ | 33 | |
| K051483 | KODAK DIRECTVIEW DR SYSTEM DETECTOR | MQB | 15 | |
| K051258 | KODAK DIRECTVIEW DR 7500 SYSTEM, MODEL 8791345 | KPR | 16 | |
| K042159 | KODAK COLOR MEDICAL IMAGER 1000 | LMC | 45 | |
| K042158 | KODAK MEDICAL IMAGER 300 | LMC | 45 | |
| K040378 | KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253 | IXA | 97 |
Source: openFDA device/510k · retrieved
Where is Eastman Kodak Company registered?
FDA lists 1 registered establishment for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what Eastman Kodak Company files next
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.