Kodak Health Imaging Systems, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Kodak Health Imaging Systems, Inc.” (first 1995, latest 1996), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 144 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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 2 | 2 |
| LMC | Camera, Multi Format, Radiological | 2 | 2 |
| LMA | Digitizer, Image, Radiological | 1 | 1 |
| LMB | Device, Digital Image Storage, Radiological | 1 | 1 |
Review panels
- Radiology (6)
Most recent Kodak Health Imaging Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K961740 | KODAK DIGITAL SCIENCE MEDICAL PRINTER INTERFACE UNIT | LLZ | 1996-11-14 | 195 |
| K961739 | KODAK DIGITAL SCIENCE MEDICAL MODALITY ACQUISITION UNIT | LLZ | 1996-11-14 | 195 |
| K961768 | KODAK DIGITAL SCIENCE FILM DIGITIZER L7501/L7506 (WITH FILM AUTOFEEDER) | LMA | 1996-08-22 | 106 |
| K960981 | KODAK DIGITAL SCIENCE(KDS) MEDICAL IMAGE AND INFORMATION LIBRARY | LMB | 1996-06-07 | 88 |
| K951948 | KODAK XLS 8600 (PS) | LMC | 1995-09-13 | 140 |
| K951807 | KODAK EKTASCAN TRIAD LASER PRINTER SYSTEM, PHOTON LASER PRINTER | LMC | 1995-09-13 | 147 |
Recalls
openFDA lists no recalls under a recalling firm named Kodak Health Imaging Systems, Inc..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Kodak Clinical Diagnostics, Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Kodak Health Imaging Systems, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Kodak Health Imaging Systems, Inc.” (first 1995, latest 1996), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Kodak Health Imaging Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kodak Health Imaging Systems, Inc. is 144 days.
Which FDA product codes appear under Kodak Health Imaging Systems, Inc.?
The most frequent FDA product codes under this applicant name are LLZ (System, Image Processing, Radiological, 2); LMC (Camera, Multi Format, Radiological, 2); LMA (Digitizer, Image, Radiological, 1).
Next steps
- See all 6 Kodak Health Imaging Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Kodak Health Imaging Systems, Inc.'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.