510(k) · Cleared
ClearedKodak EC-L Cassette
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eastman Kodak Company · IYE Accelerator, Linear, Medical
Cleared on May 28, 1996 after an 89-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it.
- Decided
- May 28, 1996
- Review
- 89 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK960834 Kodak EC-L CassetteEastman Kodak Company · 1996
- Descendant · cites it directly · 4 of its ownK032654 Port CassetteOrex Computed Radiography, Ltd. · 2003
- Descendant · 2 generations on · 1 of its ownK073670 Kodak Point of Care CR 120, Kodak Point of Care CR 140, Kodak Point…Orex Computed Radiography, Ltd. · 2008
- Descendant · 2 generations on · 1 of its ownK042779 Radiotherapy Solution Based on CRAgfa Corp. · 2004
- Descendant · 3 generations on · 0 of its ownK192894 Vita Flex CR System with LLICarestream Health, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK070920 Fuji IP Cassette Type PCFujifilm Medical Systems U.S.A, Inc. · 2007
Most influential descendants
Showing 5 of 5 · See all- K032654Port CassetteOrex Computed Radiography, Ltd. · 2003 · cites it directly4descendants
- K073670Kodak Point of Care CR 120, Kodak Point of Care CR 140, Kodak Point of Care CR 260Orex Computed Radiography, Ltd. · 2008 · 2 generations on1descendant
- K042779Radiotherapy Solution Based on CRAgfa Corp. · 2004 · 2 generations on1descendant
- K192894Vita Flex CR System with LLICarestream Health, Inc. · 2020 · 3 generations on0descendants
- K070920Fuji IP Cassette Type PCFujifilm Medical Systems U.S.A, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K960834 | Kodak EC-L Cassette | Eastman Kodak Company | 1996 | — |
| +1 | K032654 | Port Cassette | Orex Computed Radiography, Ltd. | 2003 | — |
| +2 | K073670 | Kodak Point of Care CR 120, Kodak Point of Care CR 140, Kodak Point of Care CR… | Orex Computed Radiography, Ltd. | 2008 | — |
| +2 | K042779 | Radiotherapy Solution Based on CR | Agfa Corp. | 2004 | — |
| +3 | K192894 | Vita Flex CR System with LLI | Carestream Health, Inc. | 2020 | — |
| +1 | K070920 | Fuji IP Cassette Type PC | Fujifilm Medical Systems U.S.A, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2020 | 1 | 0 |
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 IYE? 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 IYE device
- #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (5)
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?
- Of its descendants, K032654 (Orex Computed Radiography, Ltd., 2003) has gone furthest, with 4 descendants of its own.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYE
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYE
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYE
101in 2025
MAUDE reports naming product code IYE, 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 | 23 | 44 | 78 | 155 |
| 2008 | 14 | 69 | 49 | 114 |
| 2009 | 20 | 63 | 22 | 174 |
| 2010 | 23 | 74 | 27 | 246 |
| 2011 | 11 | 94 | 73 | 280 |
| 2012 | 28 | 106 | 20 | 128 |
| 2013 | 18 | 88 | 11 | 96 |
| 2014 | 20 | 100 | 14 | 124 |
| 2015 | 20 | 108 | 8 | 100 |
| 2016 | 21 | 97 | 7 | 97 |
| 2017 | 23 | 94 | 7 | 125 |
| 2018 | 21 | 58 | 7 | 85 |
| 2019 | 19 | 83 | 2 | 91 |
| 2020 | 20 | 67 | 4 | 74 |
| 2021 | 19 | 86 | 5 | 68 |
| 2022 | 12 | 172 | 3 | 66 |
| 2023 | 18 | 129 | 7 | 128 |
| 2024 | 9 | 239 | 1 | 81 |
| 2025 | 12 | 170 | 1 | 101 |
| 2026 | 14 | 120 | 4 | — |
https://510kreport.com/device/K960834 · printed Nov 4, 2026
Cite this page
510(k) Report. “K960834: Kodak EC-L Cassette.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960834
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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