510(k) Report

510(k) · Cleared

Cleared

Kodak Ektascan Imagelink System (Keis)

K931551510(k) TraditionalCleared Jun 29, 199392-day reviewClass I21 CFR 892.2020

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Eastman Kodak Company · LMD System, Digital Image Communications, Radiological

Cleared on Jun 29, 1993 after a 92-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
Jun 29, 1993
Review
92 days
Class
Class I
Product code
LMD
Recalls
None
Predicates
0

3 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 1996: 3 descendants cleared1990200020102020
  1. This deviceK931551 Kodak Ektascan Imagelink System (Keis)Eastman Kodak Company · 1993
  2. Descendant · cites it directly · 0 of its ownK961740 Kodak Digital Science Medical Printer Interface UnitKodak Health Imaging Systems, Inc. · 1996
  3. Descendant · cites it directly · 0 of its ownK961739 Kodak Digital Science Medical Modality Acquisition UnitKodak Health Imaging Systems, Inc. · 1996
  4. Descendant · cites it directly · 0 of its ownK960382 Kodak Digital Science Medical Image ManagerEastman Kodak Company · 1996

Most influential descendants

Showing 3 of 3 · See all
  • K961740Kodak Digital Science Medical Printer Interface UnitKodak Health Imaging Systems, Inc. · 1996 · cites it directly0descendants
  • K961739Kodak Digital Science Medical Modality Acquisition UnitKodak Health Imaging Systems, Inc. · 1996 · cites it directly0descendants
  • K960382Kodak Digital Science Medical Image ManagerEastman Kodak Company · 1996 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K931551Kodak Ektascan Imagelink System (Keis)Eastman Kodak Company1993—
+1K961740Kodak Digital Science Medical Printer Interface UnitKodak Health Imaging Systems, Inc.1996—
+1K961739Kodak Digital Science Medical Modality Acquisition UnitKodak Health Imaging Systems, Inc.1996—
+1K960382Kodak Digital Science Medical Image ManagerEastman Kodak Company1996—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199630
FIG. 1 — Lineage of K931551, 1993–1996Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LMD? 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (3)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K961740Kodak Digital Science Medical Printer Interface UnitKodak Health Imaging Systems, Inc.19960
K961739Kodak Digital Science Medical Modality Acquisition UnitKodak Health Imaging Systems, Inc.19960
K960382Kodak Digital Science Medical Image ManagerEastman Kodak Company19960

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?

  • Of its descendants, K961740 (Kodak Health Imaging Systems, Inc., 1996) has gone furthest, with 0 descendants of its own.

How does its category compare?

All LMD devices

LMD System, Digital Image Communications, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LMD

FDA has decided no LMD device since 2007.

Median 510(k) review, days · LMD

Too few LMD 510(k)s in any year since 2007 to give a median.

Recalls per year · LMD

2in 2020

2007: 22008: 12009: 12012: 12015: 12020: 2
2007high 2 (2007) · low 0 (2010)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LMD

16in 2025

2007: 12008: 22009: 32010: 92011: 12012: 22013: 42014: 122015: 92016: 32017: 22018: 42019: 22020: 22021: 22022: 62023: 72024: 82025: 16
2007high 16 (2025) · low 1 (2007)2025

MAUDE reports naming product code LMD, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—21
20080—12
20090—13
20100—09
20110—01
20120—12
20130—04
20140—012
20150—19
20160—03
20170—02
20180—04
20190—02
20200—22
20210—02
20220—06
20230—07
20240—08
20250—016
20260—0—

More from Eastman Kodak Company

238 FDA decisions under this applicant name. See the company

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https://510kreport.com/device/K931551 · printed Nov 6, 2026

Cite this page

510(k) Report. “K931551: Kodak Ektascan Imagelink System (Keis).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K931551

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026