510(k) · Cleared

Cleared

Kodak Color Medical Imager 1000

K042159510(k) TraditionalCleared Sep 24, 200445-day reviewClass II21 CFR 892.2040

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Eastman Kodak Company · LMC Camera, Multi Format, Radiological

Cleared on Sep 24, 2004 as substantially equivalent to K030690 (Codonics, Inc., 2003) after a 45-day review. Its family tree reaches back 3 generations to 1997.

Decided: Sep 24, 2004
Review: 45 days
Class: Class II
Product code: LMC
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K971760 (1997). 4 ancestors in all, the oldest K962364 (1996). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK971760 Colorpoint or Professional ColorpointSeiko Instruments USA, Inc. · 1997
2 generations backK991282 Colorpoint 1720 Medical Imagers and Video Capture Box CX-1000 SeriesSeiko Instruments USA, Inc. · 1999
1 generation backK030690 Codonics EP-1000 Medical Color Dry ImagersCodonics, Inc. · 2003
This deviceK042159 Kodak Color Medical Imager 1000Eastman Kodak Company · 2004

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K971760	Colorpoint or Professional Colorpoint	Seiko Instruments USA, Inc.	1997	—
−2	K991282	Colorpoint 1720 Medical Imagers and Video Capture Box CX-1000 Series	Seiko Instruments USA, Inc.	1999	—
−1	K030690	Codonics EP-1000 Medical Color Dry Imagers	Codonics, Inc.	2003	—
0 (this device)	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

FIG. 1 — Lineage of K042159, 1997–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K030690	Codonics EP-1000 Medical Color Dry Imagers Summary page 1 …O 8500 Color Printer Classification name: Medical Image Hardcopy Device 21 CFR 892.2040 Predicate device: Codonics EP-1000 Medical Color dry imager (K030690) Description And Intended Use of Device: The KODAK Color Medical Imager 1000 is intended for use as a hard copy device for out…	Codonics, Inc.	2003	—

Also cleared against K030690: 1 other device →

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 7 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
None of the 4 ancestors has a recall.
1 other device also cites its predicate K030690.

How does its category compare?

All LMC devices

LMC Camera, Multi Format, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LMC

2in 2014

2007high 3 (2009) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LMC

80in 2009

2007high 80 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LMC

1in 2008

2007high 1 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LMC

2in 2018

2007high 2 (2018) · low 0 (2007)2025

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?

Read the full statement (121 words)

The Kodak Color Medical Imager 1000 series medical printers are thermal print engines intended to produce continuous tone photographic quality, hard copy output with integrated color management that adjusts printed colors to accurately match medical image monitors or user specified color profiles. The hardcopy output includes, however is not limited to, nuclear medicine, ultrasound, CT (especially 3-D reconstruction), MRI and Radiation Therapy planning. Images are suitable for medical image diagnosis use and referral. Digital images can be acquired from, but not limited to local area networks (LAN), Internet, medical image storage devices, or directly from digital medical image capture modalities. The system of printer and physical image is not a high-resolution device and is not intended for use with FFDM systems.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K042159 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042159: Kodak Color Medical Imager 1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042159

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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