510(k) · Cleared
ClearedCypher Dicom Print Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Virtual Imaging, Inc. · LMC Camera, Multi Format, Radiological
Cleared on Oct 16, 2009 as substantially equivalent to K060440 (Codonics, Inc., 2006) and 1 other predicate after an 80-day review. Its family tree reaches back 4 generations to 2000.
- Decided
- Oct 16, 2009
- Review
- 80 days
- Class
- Class II
- Product code
- LMC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K002146 (2000). 11 ancestors in all, the oldest K962364 (1996). No later device cites it as a predicate yet.
- Root · 4 generations backK002146 Kodak Dryview 8610 Laser Imager / for MammographyEastman Kodak Company · 2000
- 3 generations backK012941 Drystar, Model 4500MAgfa Corp. · 2001
- 2 generations backK021054 Codonics Horizon CI Medical Multimedia Dry Imager; Codonics Horizon…Codonics, Inc. · 2002
- 1 generation backK042232 NP-2600 Series Hardcopy PrintersCodonics, Inc. · 2004
- This deviceK092280 Cypher Dicom Print SolutionVirtual Imaging, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K002146 | Kodak Dryview 8610 Laser Imager / for Mammography | Eastman Kodak Company | 2000 | — |
| −3 | K012941 | Drystar, Model 4500M | Agfa Corp. | 2001 | — |
| −2 | K021054 | Codonics Horizon CI Medical Multimedia Dry Imager; Codonics Horizon GS Medical… | Codonics, Inc. | 2002 | — |
| −1 | K042232 | NP-2600 Series Hardcopy Printers | Codonics, Inc. | 2004 | — |
| 0 (this device) | K092280 | Cypher Dicom Print Solution | Virtual Imaging, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2006 | 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 |
|---|---|---|---|
| * | K060440 | Codonics Horizon XL Digital Direct Long Film Imager; Codonics Horizon XL-X Long Film…Summary page 1…Regulation: 21 CFR 892.2040; Identification of Horizon® Series MEDICAL IMAGE HARDCOPY MULTIMEDIA Predicate Devices and PRINTERS, K060440 and K042232, manufactured by Codonics, Summary of Substantial Equivalence Device Description CYPHER implements t… | 2006 |
| * | K042232 | NP-2600 Series Hardcopy PrintersSummary page 1…ion: 21 CFR 892.2040; Identification of Horizon® Series MEDICAL IMAGE HARDCOPY MULTIMEDIA Predicate Devices and PRINTERS, K060440 and K042232, manufactured by Codonics, Summary of Substantial Equivalence Device Description CYPHER implements the necessary… | 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 4 companies; a new generation was cleared every 2.4 years on median.
- None of the 11 ancestors has a recall.
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?
This device is intended for high resolution hard copy imaging of digital image source material (DICOM). 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. Not for mammography use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092280 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092280: Cypher Dicom Print Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092280
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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