# K042159: Kodak Color Medical Imager 1000

- Pathway: 510(k) (Traditional)
- Applicant: Eastman Kodak Company
- Decided: Sep 24, 2004 after 45 days
- Product code: LMC (Camera, Multi Format, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K971760 (1997). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030690: Codonics EP-1000 Medical Color Dry Imagers, Codonics, Inc. (2003) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K042159
Methodology: https://510kreport.com/methodology