510(k) · Cleared
ClearedCodonics Medical Printer (NP-1600M,NP1600MD)
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 Nov 8, 1996 after a 142-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Nov 8, 1996
- Review
- 142 days
- Class
- Class II
- Product code
- LMC
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK962364 Codonics Medical Printer (NP-1600M,NP1600MD)Codonics, Inc. · 1996
- Descendant · cites it directly · 3 of its ownK030690 Codonics EP-1000 Medical Color Dry ImagersCodonics, Inc. · 2003
- Descendant · 2 generations on · 1 of its ownK042232 NP-2600 Series Hardcopy PrintersCodonics, Inc. · 2004
- Descendant · 3 generations on · 0 of its ownK092280 Cypher Dicom Print SolutionVirtual Imaging, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK042159 Kodak Color Medical Imager 1000Eastman Kodak Company · 2004
Most influential descendants
Showing 4 of 4 · See all- K030690Codonics EP-1000 Medical Color Dry ImagersCodonics, Inc. · 2003 · cites it directly3descendants
- K042232NP-2600 Series Hardcopy PrintersCodonics, Inc. · 2004 · 2 generations on1descendant
- K092280Cypher Dicom Print SolutionVirtual Imaging, Inc. · 2009 · 3 generations on0descendants
- K042159Kodak Color Medical Imager 1000Eastman Kodak Company · 2004 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K962364 | Codonics Medical Printer (NP-1600M,NP1600MD) | Codonics, Inc. | 1996 | — |
| +1 | K030690 | Codonics EP-1000 Medical Color Dry Imagers | Codonics, Inc. | 2003 | — |
| +2 | K042232 | NP-2600 Series Hardcopy Printers | Codonics, Inc. | 2004 | — |
| +3 | K092280 | Cypher Dicom Print Solution | Virtual Imaging, Inc. | 2009 | — |
| +2 | K042159 | Kodak Color Medical Imager 1000 | Eastman Kodak Company | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | — | Kodak XL7720 line of large format continuous tone printers Named without a submission number |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030690 | Codonics EP-1000 Medical Color Dry Imagers | 2003 | 3 |
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?
- Of its descendants, K030690 (Codonics, Inc., 2003) has gone furthest, with 3 descendants 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 primary intended use of this device is to create hard copy prints or transparencies of medical images acquired from computer networks typically used in a medical environment.
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/K962364 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962364: Codonics Medical Printer (NP-1600M,NP1600MD).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962364
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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