# K042158: Kodak Medical Imager 300

- 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: 1 generation back to K972163 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972163: Imation SE-196 Laser Imager, Imation Corp. (1997) Summary page 1.

## Indications for use
The KODAK Medical Imager 300 Imager is intended use as a hard copy device for output from digital imaging source modalities for use in medical imaging diagnosis and referral. Electronic image information signals are managed in the Medical Imager 300 and transformed thermally to develop Eastman Kodak imaging media. The system of printer and physical image is intended for use with a variety of modalities, including, but not limited to CR, DR, CT, MRI, Ultrasound, Nuclear Medicine, etc. for diagnostic use by medical radiologists and communications to referring physicians and their patients. 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/K042158
Methodology: https://510kreport.com/methodology