510(k) · Cleared
ClearedCodonics Horizon CI Medical Multimedia Dry Imager; Codonics Horizon GS Medical Multimedia Grey Scale Dry Imager
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Codonics, Inc. · LMC Camera, Multi Format, Radiological
Cleared on May 9, 2002 as substantially equivalent to K003481 (Codonics, Inc., 2001) and 1 other predicate after a 38-day review. Its family tree reaches back 2 generations to 2000. 6 later devices descend from it.
- Decided
- May 9, 2002
- Review
- 38 days
- Class
- Class II
- Product code
- LMC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K002146 (2000). 4 ancestors in all. 6 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK002146 Kodak Dryview 8610 Laser Imager / for MammographyEastman Kodak Company · 2000
- 1 generation backK012941 Drystar, Model 4500MAgfa Corp. · 2001
- This deviceK021054 Codonics Horizon CI Medical Multimedia Dry Imager; Codonics Horizon…Codonics, Inc. · 2002
- Descendant · cites it directly · 1 of its ownK060440 Codonics Horizon XL Digital Direct Long Film Imager; Codonics…Codonics, Inc. · 2006
- Descendant · cites it directly · 1 of its ownK042232 NP-2600 Series Hardcopy PrintersCodonics, Inc. · 2004
- Descendant · cites it directly · 1 of its ownK024188 UP-DF500 Filmstation Digital Film ImagerSony Medical Systems · 2003
- Descendant · cites it directly · 0 of its ownK111566 Dryview Chroma Imaging SystemCarestream Health, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK092280 Cypher Dicom Print SolutionVirtual Imaging, Inc. · 2009
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K060440Codonics Horizon XL Digital Direct Long Film Imager; Codonics Horizon XL-X Long Film…Codonics, Inc. · 2006 · cites it directly1descendant
- K042232NP-2600 Series Hardcopy PrintersCodonics, Inc. · 2004 · cites it directly1descendant
- K024188UP-DF500 Filmstation Digital Film ImagerSony Medical Systems · 2003 · cites it directly1descendant
- K111566Dryview Chroma Imaging SystemCarestream Health, Inc. · 2011 · cites it directly0descendants
- K092280Cypher Dicom Print SolutionVirtual Imaging, Inc. · 2009 · 2 generations on0descendants
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 | K012941 | Drystar, Model 4500M | Agfa Corp. | 2001 | — |
| 0 (this device) | K021054 | Codonics Horizon CI Medical Multimedia Dry Imager; Codonics Horizon GS Medical… | Codonics, Inc. | 2002 | — |
| +1 | K060440 | Codonics Horizon XL Digital Direct Long Film Imager; Codonics Horizon XL-X… | Codonics, Inc. | 2006 | — |
| +1 | K042232 | NP-2600 Series Hardcopy Printers | Codonics, Inc. | 2004 | — |
| +1 | K024188 | UP-DF500 Filmstation Digital Film Imager | Sony Medical Systems | 2003 | — |
| +1 | K111566 | Dryview Chroma Imaging System | Carestream Health, Inc. | 2011 | — |
| +2 | K092280 | Cypher Dicom Print Solution | Virtual Imaging, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K003481 | Codonics NP-1660 Series Medical Printers, Model 1660Summary page 3…to Medical Image Hardcopy Devices currently in commercial distribution in the U.S. We have selected the Codonics NP-1660 Series Medical Printers (Premarket notification K003481) and AGFA DryStar Models 3000 & 4500M (Premarket notification K012941) as the predicate devices for our claim of substantial equi… | 2001 |
| * | K012941 | Drystar, Model 4500MSummary page 3…n in the U.S. We have selected the Codonics NP-1660 Series Medical Printers (Premarket notification K003481) and AGFA DryStar Models 3000 & 4500M (Premarket notification K012941) as the predicate devices for our claim of substantial equivalence, Attachment 6 contains information describing these predicate… | 2001 |
| † | K962967 | Fuji Medical Dry Imager FM-DP 2636 | 1996 |
| † | K991282 | Colorpoint 1720 Medical Imagers and Video Capture Box CX-1000 Series | 1999 |
What descends from it? (6)
4 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?
- The line of descent spans 2 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K060440 (Codonics, Inc., 2006) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K003481.
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 intended uses of the Horizon® Series Imagers is high resolution hard copy imaging of digital image source material and through the conversion of electronic signals from a wide variety of direct/indirect medical imaging modality outputs. The hardcopy output includes however is not limited to, digital radiography, nuclear medicine, ultrasound, CT, MRI, CR and Radiation Therapy planning. Images are suitable for medical image diagnosis use and referral.…
Read the full statement (146 words)
The intended uses of the Horizon® Series Imagers is high resolution hard copy imaging of digital image source material and through the conversion of electronic signals from a wide variety of direct/indirect medical imaging modality outputs. The hardcopy output includes however is not limited to, digital radiography, nuclear medicine, ultrasound, CT, MRI, CR and Radiation Therapy planning. Images are suitable for medical image diagnosis use and referral. The system is intended for use by medical radiologists, imaging modality specialists, and communications to referring physicians.
The intended uses are identical to the Codonics NP-1660 Series Medical Printers (Premarket notification K003481) as a combined color, film, reflective media imager. The intended uses are identical to the FUJI FM-DP 2636 Dry Imager (Premarket notification K962967) and AGFA DryStar Model 4500M ((Premarket notification K012941) in terms of dry radiological output devices with the addition of 14 x 17 media formats.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K021054 · printed Nov 5, 2026
Cite this page
510(k) Report. “K021054: Codonics Horizon CI Medical Multimedia Dry Imager; Codonics Horizon GS Medical Multimedia Grey Scale Dry Imager.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K021054
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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