# K960382: Kodak Digital Science Medical Image Manager

- Pathway: 510(k) (Traditional)
- Applicant: Eastman Kodak Company
- Decided: Apr 17, 1996 after 83 days
- Product code: LMD (System, Digital Image Communications, Radiological)
- Device class: 1
- Regulation: 21 CFR 892.2020
- 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 K931551 (1993). 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)
- K931551: Kodak Ektascan Imagelink System (Keis), Eastman Kodak Company (1993) Summary page 2.

## Indications for use
The KODAK Digital Science Medical Image Manager will provide network access for both point -to - point and network capable image and information sources. The Image Manager will provide a value added service to point - to - point devices by adding services including routing to multiple destinations and access to multiple printers. However, evaluation of soft copy or hard copy output provides adequate opportunity for competent human intervention. PACS are not represented to be used in supporting or sustaining human life, nor do they represent a potential for unreasonable risk of illness or injury.

Source page: https://510kreport.com/device/K960382
Methodology: https://510kreport.com/methodology