510(k) · Cleared
ClearedKodak Eclipse Image Processing Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eastman Kodak Company · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Mar 16, 2006 after a 56-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 9 later devices descend from it.
- Decided
- Mar 16, 2006
- Review
- 56 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 5 citing it directly.
- This deviceK060137 Kodak Eclipse Image Processing SoftwareEastman Kodak Company · 2006
- Descendant · cites it directly · 2 of its ownK180809 Eclipse IICarestream Health, Inc. · 2018
- Descendant · cites it directly · 2 of its ownK100094 Carestream Image SuiteCarestream Heatlh, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 1 of its ownK202441 Eclipse II with Smart Noise CancellationCarestream Health, Inc. · 2021
- Descendant · 2 generations on · 1 of its ownK140271 Tablet Viewer Software for Image SuiteCarestream Health, Inc. · 2014
- Descendant · 3 generations on · 0 of its ownK251168 Image SuiteCarestream Health, Inc. · 2025
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K180809Eclipse IICarestream Health, Inc. · 2018 · cites it directly2descendants
- K100094Carestream Image SuiteCarestream Heatlh, Inc. · 2010 · cites it directly2descendants
- K202441Eclipse II with Smart Noise CancellationCarestream Health, Inc. · 2021 · 2 generations on1descendant
- K140271Tablet Viewer Software for Image SuiteCarestream Health, Inc. · 2014 · 2 generations on1descendant
- K251168Image SuiteCarestream Health, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K060137 | Kodak Eclipse Image Processing Software | Eastman Kodak Company | 2006 | — |
| +1 | K180809 | Eclipse II | Carestream Health, Inc. | 2018 | — |
| +1 | K100094 | Carestream Image Suite | Carestream Heatlh, Inc. | 2010 | 2 |
| +2 | K202441 | Eclipse II with Smart Noise Cancellation | Carestream Health, Inc. | 2021 | — |
| +2 | K140271 | Tablet Viewer Software for Image Suite | Carestream Health, Inc. | 2014 | — |
| +3 | K251168 | Image Suite | Carestream Health, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MQB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MQB device
- #1 K201528 Yushan X-Ray Flat Panel Detector with DROCscore 21.5 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (9)
5 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?
- Of its descendants, K180809 (Carestream Health, Inc., 2018) has gone furthest, with 2 descendants of its own.
How does its category compare?
All MQB devicesMQB Solid State X-Ray Imager (Flat Panel/Digital Imager): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MQB
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQB
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQB
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQB
141in 2025
MAUDE reports naming product code MQB, 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 | 13 | 22 | 15 | 25 |
| 2008 | 8 | 15 | 36 | 30 |
| 2009 | 15 | 57 | 19 | 34 |
| 2010 | 11 | 116 | 14 | 39 |
| 2011 | 24 | 102 | 10 | 101 |
| 2012 | 22 | 80 | 8 | 267 |
| 2013 | 21 | 105 | 6 | 159 |
| 2014 | 32 | 102 | 0 | 29 |
| 2015 | 21 | 81 | 0 | 21 |
| 2016 | 22 | 92 | 0 | 26 |
| 2017 | 31 | 30 | 1 | 20 |
| 2018 | 16 | 30 | 4 | 84 |
| 2019 | 22 | 30 | 1 | 45 |
| 2020 | 19 | 28 | 4 | 9 |
| 2021 | 21 | 48 | 1 | 26 |
| 2022 | 31 | 48 | 0 | 13 |
| 2023 | 10 | 30 | 0 | 51 |
| 2024 | 8 | 187 | 0 | 91 |
| 2025 | 8 | 127 | 1 | 141 |
| 2026 | 3 | 245 | 1 | — |
What is it indicated for?
The CR Systems are compact laser scanners capable of reading the latent image formed on a storage phosphor imaging plate and producing a digital image for projection radiography applications. This excludes mammography applications for the Kodak Ektascan Storage Phosphor Reader and the Kodak Eclipse image Processing Software in the United States.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K060137 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060137: Kodak Eclipse Image Processing Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060137
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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