# K972847: Kodak Digital Science 9000D Medical Laser Printer (9000D)

- Pathway: 510(k) (Traditional)
- Applicant: Eastman Kodak Company
- Decided: Oct 7, 1997 after 67 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The KODAK Digital Science 9000D Medical Laser Printer is a laser printer designed to produce hard-copy films of digitized medical images. It is a newly designed printer to be added to Kodak’s family of medical laser printer products that is intended for the centralized network printing solution for high volume sites for maximum productivity. This printer will be environmentally friendly by eliminating wet chemistry, site concerns, costs and will reduce chemical disposal problems. This is accomplished by using a totally proprietary imaging process. Images printed on film from the laser printer will be used for primary diagnosis, similar to other laser printers and CRT mult-format cameras. Evaluation of the hard copy output by trained health care professionals provides adequate opportunity for competent human intervention. Laser printers are not represented to be of use in supporting or sustaining human life, nor do they present a potential for unreasonable risk of illness or injury.

Source page: https://510kreport.com/device/K972847
Methodology: https://510kreport.com/methodology