510(k) · Cleared
ClearedCarestream Dryview 5850 Laser Imager
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carestream Health, Inc. · LMC Camera, Multi Format, Radiological
Cleared on May 22, 2009 as substantially equivalent to K033821 (Eastman Kodak Company, 2004) after an 88-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- May 22, 2009
- Review
- 88 days
- Class
- Class II
- Product code
- LMC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K002146 (2000). No later device cites it as a predicate yet.
- Root · 2 generations backK002146 Kodak Dryview 8610 Laser Imager / for MammographyEastman Kodak Company · 2000
- 1 generation backK033821 Kodak Dryview 8900 Laser Imager Mammography AccessoryEastman Kodak Company · 2004
- This deviceK090469 Carestream Dryview 5850 Laser ImagerCarestream Health, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002146 | Kodak Dryview 8610 Laser Imager / for Mammography | Eastman Kodak Company | 2000 | — |
| −1 | K033821 | Kodak Dryview 8900 Laser Imager Mammography Accessory | Eastman Kodak Company | 2004 | — |
| 0 (this device) | K090469 | Carestream Dryview 5850 Laser Imager | Carestream Health, Inc. | 2009 | — |
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 |
|---|---|---|---|
| * | K033821 | Kodak Dryview 8900 Laser Imager Mammography AccessorySummary page 1…n name: Medical Image Hardcopy Device (21 CFR 892.2040) Predicate device Kodak DRYVIEW 8900 Laser Imager with Mammography Accessory (K033821) Description and Intended Use of Device The CARESTREAM DRYVIEW 5850 Laser Imager is intended to provide high- resolution hard co… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 5.3 years on median.
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K033821.
How does its category compare?
All LMC devicesLMC Camera, Multi Format, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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 CARESTREAM DRYVIEW 5850 Laser Imager is intended to provide high-resolution hard copy images from digital imaging source output signals. The device is intended for use with KODAK DRYVIEW media including DVM (DryView mammography) films. The imager will interface with a variety of digital modalities, including, but not limited to, CR (Computed Radiology), DR (Digital Radiology), CT (Computerized Tomography), MRI (Magnetic Resonance Imaging) and FFDM (Full Field Digital mammography). Image resizing is used to preserve true geometric size images. The images are to be used for medical diagnosis and referral to physicians and their patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090469 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090469: Carestream Dryview 5850 Laser Imager.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090469
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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