510(k) · Cleared
ClearedCodonics EP-1000 Medical Color Dry Imagers
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 Apr 30, 2003 as substantially equivalent to K962364 (Codonics, Inc., 1996) and 1 other predicate after a 56-day review. Its family tree reaches back 2 generations to 1997. 3 later devices descend from it.
- Decided
- Apr 30, 2003
- Review
- 56 days
- Class
- Class II
- Product code
- LMC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K971760 (1997). 3 ancestors in all, the oldest K962364 (1996). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK971760 Colorpoint or Professional ColorpointSeiko Instruments USA, Inc. · 1997
- 1 generation backK991282 Colorpoint 1720 Medical Imagers and Video Capture Box CX-1000 SeriesSeiko Instruments USA, Inc. · 1999
- This deviceK030690 Codonics EP-1000 Medical Color Dry ImagersCodonics, Inc. · 2003
- Descendant · cites it directly · 1 of its ownK042232 NP-2600 Series Hardcopy PrintersCodonics, Inc. · 2004
- Descendant · 2 generations on · 0 of its ownK092280 Cypher Dicom Print SolutionVirtual Imaging, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK042159 Kodak Color Medical Imager 1000Eastman Kodak Company · 2004
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K971760 | Colorpoint or Professional Colorpoint | Seiko Instruments USA, Inc. | 1997 | — |
| −1 | K991282 | Colorpoint 1720 Medical Imagers and Video Capture Box CX-1000 Series | Seiko Instruments USA, Inc. | 1999 | — |
| 0 (this device) | K030690 | Codonics EP-1000 Medical Color Dry Imagers | Codonics, Inc. | 2003 | — |
| +1 | K042232 | NP-2600 Series Hardcopy Printers | Codonics, Inc. | 2004 | — |
| +2 | K092280 | Cypher Dicom Print Solution | Virtual Imaging, Inc. | 2009 | — |
| +1 | K042159 | Kodak Color Medical Imager 1000 | Eastman Kodak Company | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K962364 | Codonics Medical Printer (NP-1600M,NP1600MD)Summary page 1…000 Medical Color Dry Imagers 2.5 Predicate Devices: Codonics NP-1600 Series Medical Printers (Premarket notification K962364) and Seiko ColorPoint 1720 (Premarket notification K991282). 3 Device Description… | 1996 |
| * | K991282 | Colorpoint 1720 Medical Imagers and Video Capture Box CX-1000 SeriesSummary page 1…cal Printers (Premarket notification K962364) and Seiko ColorPoint 1720 (Premarket notification K991282). 3 Device Description 807.92(a)(4) 3.1 Function The EP-1000 Imagers are dry, thermal, color p… | 1999 |
| † | K021054 | Codonics Horizon CI Medical Multimedia Dry Imager; Codonics Horizon GS Medical… | 2002 |
What descends from it? (3)
2 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 6 years and passes through 2 companies; a new generation was cleared every 3.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K042232 (Codonics, Inc., 2004) has gone furthest, with 1 descendant of its own.
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 EP-1000 Imagers is high resolution hard copy imaging of digital image source material and through the conversion of electronic signals from a wide variety of diredindirect medical imaging modality outputs. The hardcopy output includes however is not limited to, nuclear medicine, ultrasound, CT (especially 3-0 reconstruction), MRI, and Radiation Therapy planning. Images are suitable for medical image diagnosis use and referral.…
Read the full statement (124 words)
The intended uses of the EP-1000 Imagers is high resolution hard copy imaging of digital image source material and through the conversion of electronic signals from a wide variety of diredindirect medical imaging modality outputs. The hardcopy output includes however is not limited to, nuclear medicine, ultrasound, CT (especially 3-0 reconstruction), MRI, 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-1600 Series Medical Printers (Premarket notification K962364) as a color, reflective media imager. The intended uses are identical to the Seiko ColorPoint 1720 (Premarket notification K991282) in terms of color, reflective media output.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030690 · printed Nov 3, 2026
Cite this page
510(k) Report. “K030690: Codonics EP-1000 Medical Color Dry Imagers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K030690
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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