510(k) · Cleared
ClearedKodak Dryview 8610 Laser Imager / for Mammography
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eastman Kodak Company · LMC Camera, Multi Format, Radiological
Cleared on Sep 27, 2000 after a 72-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 14 later devices descend from it.
- Decided
- Sep 27, 2000
- Review
- 72 days
- Class
- Class II
- Product code
- LMC
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 3 citing it directly.
- This deviceK002146 Kodak Dryview 8610 Laser Imager / for MammographyEastman Kodak Company · 2000
- Descendant · cites it directly · 8 of its ownK012941 Drystar, Model 4500MAgfa Corp. · 2001
- Descendant · 2 generations on · 6 of its ownK021054 Codonics Horizon CI Medical Multimedia Dry Imager; Codonics Horizon…Codonics, Inc. · 2002
- Descendant · cites it directly · 4 of its ownK033821 Kodak Dryview 8900 Laser Imager Mammography AccessoryEastman Kodak Company · 2004
- Descendant · 2 generations on · 2 of its ownK042133 Dry Laser Imager, Model Drypro Model 793Konica Minolta Medical & Graphic, Inc. · 2004
- Descendant · 3 generations on · 1 of its ownK060440 Codonics Horizon XL Digital Direct Long Film Imager; Codonics…Codonics, Inc. · 2006
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K012941Drystar, Model 4500MAgfa Corp. · 2001 · cites it directly8descendants
- K021054Codonics Horizon CI Medical Multimedia Dry Imager; Codonics Horizon GS Medical…Codonics, Inc. · 2002 · 2 generations on6descendants
- K033821Kodak Dryview 8900 Laser Imager Mammography AccessoryEastman Kodak Company · 2004 · cites it directly4descendants
- K042133Dry Laser Imager, Model Drypro Model 793Konica Minolta Medical & Graphic, Inc. · 2004 · 2 generations on2descendants
- K060440Codonics Horizon XL Digital Direct Long Film Imager; Codonics Horizon XL-X Long Film…Codonics, Inc. · 2006 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002146 | Kodak Dryview 8610 Laser Imager / for Mammography | Eastman Kodak Company | 2000 | — |
| +1 | K012941 | Drystar, Model 4500M | Agfa Corp. | 2001 | — |
| +2 | K021054 | Codonics Horizon CI Medical Multimedia Dry Imager; Codonics Horizon GS Medical… | Codonics, Inc. | 2002 | — |
| +1 | K033821 | Kodak Dryview 8900 Laser Imager Mammography Accessory | Eastman Kodak Company | 2004 | — |
| +2 | K042133 | Dry Laser Imager, Model Drypro Model 793 | Konica Minolta Medical & Graphic, Inc. | 2004 | — |
| +3 | K060440 | Codonics Horizon XL Digital Direct Long Film Imager; Codonics Horizon XL-X… | Codonics, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2011 | 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 LMC? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (14)
See all 143 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, K012941 (Agfa Corp., 2001) has gone furthest, with 8 descendants of its own.
How does its category compare?
All LMC devicesLMC Camera, Multi Format, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LMC
2in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · LMC
80in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LMC
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LMC
2in 2018
MAUDE reports naming product code LMC, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 1 | 0 |
| 2009 | 3 | 80 | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K002146 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002146: Kodak Dryview 8610 Laser Imager / for Mammography.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002146
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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