510(k) · Cleared
ClearedKodak Digital Science 9000D Medical Laser Printer (9000D)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eastman Kodak Company · LMC Camera, Multi Format, Radiological
Cleared on Oct 7, 1997 after a 67-day review. The FDA summary names no predicate by number.
- Decided
- Oct 7, 1997
- Review
- 67 days
- Class
- Class II
- Product code
- LMC
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LMC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All LMC devicesLMC Camera, Multi Format, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LMC
2in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · LMC
80in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LMC
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LMC
2in 2018
MAUDE reports naming product code LMC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 1 | 0 |
| 2009 | 3 | 80 | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The KODAK Digital Science 9000D Medical Laser Printer is a laser printer designed to produce hard-copy films of digitized medical images. It is a newly designed printer to be added to Kodak’s family of medical laser printer products that is intended for the centralized network printing solution for high volume sites for maximum productivity. This printer will be environmentally friendly by eliminating wet chemistry, site concerns, costs and will reduce…
Read the full statement (152 words)
The KODAK Digital Science 9000D Medical Laser Printer is a laser printer designed to produce hard-copy films of digitized medical images. It is a newly designed printer to be added to Kodak’s family of medical laser printer products that is intended for the centralized network printing solution for high volume sites for maximum productivity. This printer will be environmentally friendly by eliminating wet chemistry, site concerns, costs and will reduce chemical disposal problems. This is accomplished by using a totally proprietary imaging process.
Images printed on film from the laser printer will be used for primary diagnosis, similar to other laser printers and CRT mult-format cameras. Evaluation of the hard copy output by trained health care professionals provides adequate opportunity for competent human intervention. Laser printers are not represented to be of use in supporting or sustaining human life, nor do they present a potential for unreasonable risk of illness or injury.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972847 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972847: Kodak Digital Science 9000D Medical Laser Printer (9000D).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972847
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026