510(k) · Cleared
ClearedKodak Digital Science 3600 Distributed Medical Imager, Kodak Digital Science 1200 Distributed Medical Imager, Model 3600
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 Jan 25, 1999 as substantially equivalent to K951948 (Kodak Health Imaging Systems, Inc., 1995) after an 83-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.
- Decided
- Jan 25, 1999
- Review
- 83 days
- Class
- Class II
- Product code
- LMC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K951948 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK951948 Kodak XLS 8600 (PS)Kodak Health Imaging Systems, Inc. · 1995
- This deviceK983905 Kodak Digital Science 3600 Distributed Medical Imager, Kodak Digital…Eastman Kodak Company · 1999
- Descendant · cites it directly · 0 of its ownK011617 Lifejet Printer 400Ferrania S.P.A. Stabilimento DI Ferrania · 2001
Most influential descendants
Showing 1 of 1 · See all- K011617Lifejet Printer 400Ferrania S.P.A. Stabilimento DI Ferrania · 2001 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K951948 | Kodak XLS 8600 (PS) | Kodak Health Imaging Systems, Inc. | 1995 | — |
| 0 (this device) | K983905 | Kodak Digital Science 3600 Distributed Medical Imager, Kodak Digital Science… | Eastman Kodak Company | 1999 | — |
| +1 | K011617 | Lifejet Printer 400 | Ferrania S.P.A. Stabilimento DI Ferrania | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K951948 | Kodak XLS 8600 (PS)Summary page 1…classified the predicate device as Regulatory Class Il under CFR 892.1750 VI. Predicate Device KODAK EKTASCAN Medical Color Imager 2000PS (‘KEMCI 2000’); 510(k) number K951948 VII. Description of Devices KODAK DIGITAL SCIENCE 3600 Distributed Medical Imager is designed for mid to high end desktop Refer… | 1995 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K011617 | Lifejet Printer 400 | 2001 | 0 |
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.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K011617 (Ferrania S.P.A. Stabilimento DI Ferrania, 2001) has gone furthest, with 0 descendants of its own.
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?
KODAK DIGITAL SCIENCE Distributed Medical Imagers are computer peripheral printing devices used to make hard copy of medical images and reports on paper and/or film.
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/K983905 · printed Nov 5, 2026
Cite this page
510(k) Report. “K983905: Kodak Digital Science 3600 Distributed Medical Imager, Kodak Digital Science 1200 Distributed Medical Imager, Model 3600.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983905
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026