510(k) · Cleared

Cleared

Kodak Digital Science Medical Image Manager

K960382510(k) TraditionalCleared Apr 17, 199683-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 Apr 17, 1996 as substantially equivalent to K931551 (Eastman Kodak Company, 1993) after an 83-day review. Its family tree reaches back 1 generation to 1993.

Decided: Apr 17, 1996
Review: 83 days
Class: Class I
Product code: LMD
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K931551 (1993). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK931551 Kodak Ektascan Imagelink System (Keis)Eastman Kodak Company · 1993
This deviceK960382 Kodak Digital Science Medical Image ManagerEastman Kodak Company · 1996

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K931551	Kodak Ektascan Imagelink System (Keis)	Eastman Kodak Company	1993	—
0 (this device)	K960382	Kodak Digital Science Medical Image Manager	Eastman Kodak Company	1996	—

FIG. 1 — Lineage of K960382, 1993–1996Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 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? (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	Applicant	Decided	Recalls
*	K931551	Kodak Ektascan Imagelink System (Keis) Summary page 2 …able risk of illness or injury. V. COMPARISON OF FEATURES KODAK EKTASCAN IMAGELINK Ultrasound System KODAK DIGITAL SCIENCE Remote Network Interface eneral K-Number K-931551 This 510(k) Power 90-132VAC/47-63Hz 100VAC +/-10%,50/60 Hz (+/-2%)250w Requirements 180-264VAC/47-63Hz 120VAC +/-10%,60Hz (+/-2%)…	Eastman Kodak Company	1993	—

Also cleared against K931551: 2 other devices →

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?

Its one ancestor has no recall.
2 other devices also cite its predicate K931551.

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

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

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

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	2	1
2008	—	1	2
2009	—	1	3
2010	—	0	9
2011	—	0	1
2012	—	1	2
2013	—	0	4
2014	—	0	12
2015	—	1	9
2016	—	0	3
2017	—	0	2
2018	—	0	4
2019	—	0	2
2020	—	2	2
2021	—	0	2
2022	—	0	6
2023	—	0	7
2024	—	0	8
2025	—	0	16
2026	—	0	—

What is it indicated for?

The KODAK Digital Science Medical Image Manager will provide network access for both point -to - point and network capable image and information sources. The Image Manager will provide a value added service to point - to - point devices by adding services including routing to multiple destinations and access to multiple printers. However, evaluation of soft copy or hard copy output provides adequate opportunity for competent human intervention. PACS are not represented to be used in supporting or sustaining human life, nor do they represent 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/K960382 · printed Nov 5, 2026

Cite this page

510(k) Report. “K960382: Kodak Digital Science Medical Image Manager.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K960382

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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