510(k) · Cleared
ClearedKodak Digital Sciences (KDS) Image View
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eastman Kodak Company · LMD System, Digital Image Communications, Radiological
Cleared on Jun 18, 1998 as substantially equivalent to K971347 (International Regulatory Consultants, 1997) after an 87-day review. Its family tree reaches back 2 generations to 1996. 1 later device descends from it.
- Decided
- Jun 18, 1998
- Review
- 87 days
- Class
- Class I
- Product code
- LMD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K954678 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 1 generation backK971347 MedisurfInternational Regulatory Consultants · 1997
- This deviceK981053 Kodak Digital Sciences (KDS) Image ViewEastman Kodak Company · 1998
- Descendant · cites it directly · 0 of its ownK984405 Echolive Family, Models: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000Intracom Corp. · 1999
Most influential descendants
Showing 1 of 1 · See all- K984405Echolive Family, Models: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000Intracom Corp. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −1 | K971347 | Medisurf | International Regulatory Consultants | 1997 | — |
| 0 (this device) | K981053 | Kodak Digital Sciences (KDS) Image View | Eastman Kodak Company | 1998 | — |
| +1 | K984405 | Echolive Family, Models: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000 | Intracom Corp. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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 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
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 |
|---|---|---|---|
| * | K971347 | MedisurfSummary page 1…as Unclassified (Product Code 90 LMD) under 21 CFR 892.1750. PREDICATE DEVICE Trade Name: MediSurf, currently marketed in the United States by Algotec Systems, Ltd. (K971347) DESCRIPTION OF DEVICE The Kodak Digital Science™ (KDS) ImageVIEW family of products is designed to facilitate the distribution… | 1997 |
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 |
|---|---|---|---|
| K984405 | Echolive Family, Models: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000 | 1999 | 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?
- The line of descent spans 2 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K984405 (Intracom Corp., 1999) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K971347.
How does its category compare?
All LMD devicesLMD 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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LMD
16in 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 | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 2 | 1 |
| 2008 | 0 | — | 1 | 2 |
| 2009 | 0 | — | 1 | 3 |
| 2010 | 0 | — | 0 | 9 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 1 | 2 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 12 |
| 2015 | 0 | — | 1 | 9 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 2 | 2 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 6 |
| 2023 | 0 | — | 0 | 7 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 16 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Kodak Digital Science™ (KDS) ImageVIEW is a network-oriented client/server type PACS system for the distribution, viewing, and printing of medical images at distributed locations.
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/K981053 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981053: Kodak Digital Sciences (KDS) Image View.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981053
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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