510(k) · Cleared
ClearedCodonics Horizon XL Digital Direct Long Film Imager; Codonics Horizon XL-X Long Film 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 Mar 16, 2006 as substantially equivalent to K021054 (Codonics, Inc., 2002) after a 23-day review. Its family tree reaches back 3 generations to 2000. 1 later device descends from it.
- Decided
- Mar 16, 2006
- Review
- 23 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. 1 later device descends from it, 1 citing it directly.
- 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 deviceK060440 Codonics Horizon XL Digital Direct Long Film Imager; Codonics…Codonics, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK092280 Cypher Dicom Print SolutionVirtual Imaging, Inc. · 2009
Most influential descendants
Showing 1 of 1 · See all- K092280Cypher Dicom Print SolutionVirtual Imaging, Inc. · 2009 · cites it directly0descendants
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) | K060440 | Codonics Horizon XL Digital Direct Long Film Imager; Codonics Horizon XL-X… | Codonics, Inc. | 2006 | — |
| +1 | 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 |
|---|---|---|
| 2009 | 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? (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 2…s MEDICAL IMAGE HARDCOPY MULTIMEDIA PRINTERS Device Modification to Cleared Device K021054 Model Horizon XL- Long Film Imager Model Ho… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092280 | Cypher Dicom Print Solution | 2009 | 0 |
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 6 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K092280 (Virtual Imaging, Inc., 2009) has gone furthest, with 0 descendants of its own.
- 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.
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 XL are identical to the Codonics Horizon® Series Medical Hardcopy Dry Imagers (premarket notification K021054); high resolution hard copy imaging of digital image source material combining color, film, reflective media in one imager. 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…
Read the full statement (153 words)
The intended uses of the Horizon XL are identical to the Codonics Horizon® Series Medical Hardcopy Dry Imagers (premarket notification K021054); high resolution hard copy imaging of digital image source material combining color, film, reflective media in one imager. 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 addition of 14" x 36" and 14" x 51" true size "long" film and (TBD) reflective Direct Vista Paper media permits digital direct orthopaedic application hardcopy including diagnosis and analysis of scoliosis, weight bearing spine/hip/knee, and long bone/hip Prosthetic and orthopedic appliances work-up and surgical planning. Horizon XL is applicable to true-size hardcopy of whole body CT, MRI and Angiographic and Venous flow imaging procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060440 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060440: Codonics Horizon XL Digital Direct Long Film Imager; Codonics Horizon XL-X Long Film Imager.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060440
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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