510(k) · Cleared
ClearedLifejet Printer 400
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ferrania S.P.A. Stabilimento DI Ferrania · LMC Camera, Multi Format, Radiological
Cleared on Jun 8, 2001 as substantially equivalent to K983905 (Eastman Kodak Company, 1999) after a 14-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Jun 8, 2001
- Review
- 14 days
- Class
- Class II
- Product code
- LMC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K951948 (1995). No later device cites it as a predicate yet.
- Root · 2 generations backK951948 Kodak XLS 8600 (PS)Kodak Health Imaging Systems, Inc. · 1995
- 1 generation backK983905 Kodak Digital Science 3600 Distributed Medical Imager, Kodak Digital…Eastman Kodak Company · 1999
- This deviceK011617 Lifejet Printer 400Ferrania S.P.A. Stabilimento DI Ferrania · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K951948 | Kodak XLS 8600 (PS) | Kodak Health Imaging Systems, Inc. | 1995 | — |
| −1 | K983905 | Kodak Digital Science 3600 Distributed Medical Imager, Kodak Digital Science… | Eastman Kodak Company | 1999 | — |
| 0 (this device) | K011617 | Lifejet Printer 400 | Ferrania S.P.A. Stabilimento DI Ferrania | 2001 | — |
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 |
|---|---|---|---|
| * | K983905 | Kodak Digital Science 3600 Distributed Medical Imager, Kodak Digital Science 1200…Summary page 1…ame: LifeJet™ Printer 400 Classification Name: Medical image hardcopy device (per 21 CFR 892.2040) KODAK DIGITAL SCIENCE 1200 Distributed Medical Imager (510(k) number: K983905) Eastman Kodak Company Health Imaging Division 343 State Street Rochester, NY 14650 The LifeJet™ Printer 400 is an inkjet pri… | 1999 |
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.
What does this lineage say?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
- None of the 2 ancestors has a 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 LifeJet™ Printer 400 is an ink jet printer designed to provide
referral high quality color and/or gray scale hard copies of medical
images generated by medical equipment.
The LifeJet™ Printer 400 has been developed to be used together with
LifeJet™ Medical Paper and LifeJet™ Medical Ink Jet Cartridges to
achieve the best quality medical images.
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/K011617 · printed Nov 5, 2026
Cite this page
510(k) Report. “K011617: Lifejet Printer 400.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011617
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026