510(k) · Cleared
ClearedDryview Chroma Imaging System
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 Oct 6, 2011 as substantially equivalent to K021054 (Codonics, Inc., 2002) after a 122-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Oct 6, 2011
- Review
- 122 days
- Class
- Class II
- Product code
- LMC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K002146 (2000). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK002146 Kodak Dryview 8610 Laser Imager / for MammographyEastman Kodak Company · 2000
- 2 generations backK012941 Drystar, Model 4500MAgfa Corp. · 2001
- 1 generation backK021054 Codonics Horizon CI Medical Multimedia Dry Imager; Codonics Horizon…Codonics, Inc. · 2002
- This deviceK111566 Dryview Chroma Imaging SystemCarestream Health, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002146 | Kodak Dryview 8610 Laser Imager / for Mammography | Eastman Kodak Company | 2000 | — |
| −2 | K012941 | Drystar, Model 4500M | Agfa Corp. | 2001 | — |
| −1 | K021054 | Codonics Horizon CI Medical Multimedia Dry Imager; Codonics Horizon GS Medical… | Codonics, Inc. | 2002 | — |
| 0 (this device) | K111566 | Dryview Chroma Imaging System | Carestream Health, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 |
|---|---|---|---|
| * | K021054 | Codonics Horizon CI Medical Multimedia Dry Imager; Codonics Horizon GS Medical…Summary page 1…ation name: Medical Image Hardcopy Device (21 CFR 692.2040) Predicate device Codonics Horizon Ci Medical Image Multimedia Imager (K(021054) Description and Intended Use of Device The DRYVIEW CHROMA Imaging System is intended to provide hard copy images from digital i… | 2002 |
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 11 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- None of the 5 ancestors has a recall.
- 3 other devices also cite its predicate K021054.
How does its category compare?
All LMC devicesLMC Camera, Multi Format, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 DRYVIEW CHROMA Imaging System is intended to provide hard copy images from digital imaging source output signals. The device is intended for use with DRYVIEW CHROMA film and reflective media. The printer will interface with a variety of digital modalities, including, but not limited to, CR (Computed Radiology), DR (Digital Radiology), CT (Computerized Tomography) and MRI (Magnetic Resonance Imaging). The images are to be used for medical diagnosis and referral to physicians and their patients. The DRYVIEW CHROMA Imaging System is not intended for use wit FFDM or CR Mammography systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111566 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111566: Dryview Chroma Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111566
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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