510(k) · Cleared
ClearedKodak Dryview 8900 Laser Imager Mammography Accessory
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 Feb 20, 2004 as substantially equivalent to K002146 (Eastman Kodak Company, 2000) after a 73-day review. Its family tree reaches back 1 generation to 2000. 4 later devices descend from it.
- Decided
- Feb 20, 2004
- Review
- 73 days
- Class
- Class II
- Product code
- LMC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002146 (2000). 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK002146 Kodak Dryview 8610 Laser Imager / for MammographyEastman Kodak Company · 2000
- This deviceK033821 Kodak Dryview 8900 Laser Imager Mammography AccessoryEastman Kodak Company · 2004
- Descendant · cites it directly · 2 of its ownK042133 Dry Laser Imager, Model Drypro Model 793Konica Minolta Medical & Graphic, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK090469 Carestream Dryview 5850 Laser ImagerCarestream Health, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK083522 Sony UP-DF750 Digital Film ImagerSony Electronics, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK081637 Laser Imager Drypro Model 873Konica Minolta Medical & Graphic, Inc. · 2008
Most influential descendants
Showing 4 of 4 · See all- K042133Dry Laser Imager, Model Drypro Model 793Konica Minolta Medical & Graphic, Inc. · 2004 · cites it directly2descendants
- K090469Carestream Dryview 5850 Laser ImagerCarestream Health, Inc. · 2009 · cites it directly0descendants
- K083522Sony UP-DF750 Digital Film ImagerSony Electronics, Inc. · 2009 · cites it directly0descendants
- K081637Laser Imager Drypro Model 873Konica Minolta Medical & Graphic, Inc. · 2008 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002146 | Kodak Dryview 8610 Laser Imager / for Mammography | Eastman Kodak Company | 2000 | — |
| 0 (this device) | K033821 | Kodak Dryview 8900 Laser Imager Mammography Accessory | Eastman Kodak Company | 2004 | — |
| +1 | K042133 | Dry Laser Imager, Model Drypro Model 793 | Konica Minolta Medical & Graphic, Inc. | 2004 | — |
| +1 | K090469 | Carestream Dryview 5850 Laser Imager | Carestream Health, Inc. | 2009 | — |
| +1 | K083522 | Sony UP-DF750 Digital Film Imager | Sony Electronics, Inc. | 2009 | — |
| +2 | K081637 | Laser Imager Drypro Model 873 | Konica Minolta Medical & Graphic, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 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 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? (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 |
|---|---|---|---|
| * | K002146 | Kodak Dryview 8610 Laser Imager / for MammographySummary page 1…ification name: Medical Image Hardcopy Device 21 CFR 892.2040 Predicate device: Kodak DRYVIEW 861 0 Laser Imager/ for Mammography (K002146) Description And Intended Use of Device: The KODAK DRYVIEW 8900 Laser Imager Mammography Accessory's intended use is as a hard… | 2000 |
What descends from it? (4)
3 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?
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 | — |
What is it indicated for?
The KODAK DRYVIEW 8900 Laser Imager with Mammography Accessory is intended to provide high-resolution hard copy images from digital imaging source output signals. The device is intended for use with KODAK DRYVIEW DVM film for use with a variety of digital modalities, including, but not limited to, CR (Computed Radiology), DR (Digital Radiology) and FFDM (Full Field Digital mammography). The images are to be used for medical diagnosis medical and referring physicians and their patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033821 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033821: Kodak Dryview 8900 Laser Imager Mammography Accessory.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033821
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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