510(k) · Cleared
ClearedKodak Digital Science (KDS) Medical Image and Information Library
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kodak Health Imaging Systems, Inc. · LMB Device, Digital Image Storage, Radiological
Cleared on Jun 7, 1996 as substantially equivalent to K915094 (Vortech Data, Inc., 1991) after an 88-day review. Its family tree reaches back 1 generation to 1991. 2 later devices descend from it.
- Decided
- Jun 7, 1996
- Review
- 88 days
- Class
- Class I
- Product code
- LMB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K915094 (1991). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK915094 Vortech's Image Archival and Retrieval SystemVortech Data, Inc. · 1991
- This deviceK960981 Kodak Digital Science (KDS) Medical Image and Information LibraryKodak Health Imaging Systems, Inc. · 1996
- Descendant · cites it directly · 0 of its ownK980243 Parameter Developments Dicom Archival Server, (Das)/Dicom Intranet…Parameter Developments, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK972380 Kodak Digital Science (KDS) Medical Image and Information Library…Eastman Kodak Company · 1997
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K915094 | Vortech's Image Archival and Retrieval System | Vortech Data, Inc. | 1991 | — |
| 0 (this device) | K960981 | Kodak Digital Science (KDS) Medical Image and Information Library | Kodak Health Imaging Systems, Inc. | 1996 | — |
| +1 | K980243 | Parameter Developments Dicom Archival Server, (Das)/Dicom Intranet Service (Dis) | Parameter Developments, Inc. | 1998 | — |
| +1 | K972380 | Kodak Digital Science (KDS) Medical Image and Information Library (Miil) | Eastman Kodak Company | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 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 LMB? 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 |
|---|---|---|---|
| * | K915094 | Vortech's Image Archival and Retrieval SystemSummary page 1…SSIFICATION FDA has classified the predicate device as Regulatory Class II under 21 CFR 892.1750. PREDICATE DEVICE Vortech (Kodak) Image Archive and Retrieval System--K915094 KODAK DIGITAL SCIENCE Premarket Notification VII. DESCRIPTION OF DEVICE The system consists of three main compon… | 1991 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K980243 (Parameter Developments, Inc., 1998) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LMB devicesLMB Device, Digital Image Storage, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LMB
FDA has decided no LMB device since 2007.
Median 510(k) review, days · LMB
Too few LMB 510(k)s in any year since 2007 to give a median.
Recalls per year · LMB
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LMB
7in 2025
MAUDE reports naming product code LMB, 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 | — | 0 | 1 |
| 2008 | 0 | — | 1 | 3 |
| 2009 | 0 | — | 5 | 3 |
| 2010 | 0 | — | 0 | 16 |
| 2011 | 0 | — | 2 | 4 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 0 | — | 1 | 7 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 21 |
| 2017 | 0 | — | 0 | 10 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 10 |
| 2020 | 0 | — | 0 | 8 |
| 2021 | 0 | — | 0 | 10 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 10 |
| 2024 | 0 | — | 0 | 9 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The KODAK DIGITAL SCIENCE (KDS) Medical Image and Information Library is a DICOM conformant archival product designed for use within a Picture Archiving and Communication System (PACS). The system utilizes a prefetching algorithm to facilitate fast access to previous imagery.
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/K960981 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960981: Kodak Digital Science (KDS) Medical Image and Information Library.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960981
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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