# K984409: Elk Laser Film Digitizer

- Pathway: 510(k) (Traditional)
- Applicant: Nishimoto Sangyo Co., Ltd.
- Decided: Feb 12, 1999 after 65 days
- Product code: LMA (Digitizer, Image, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K934496 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974315: Vidar VXR LS Laser Film Digitizer, Vidar Systems Corp. (1998) Summary page 1.

## Indications for use
The Model ED-3000 is a desk top laser image digitizer intended to produce digital copies of radiological film.

Source page: https://510kreport.com/device/K984409
Methodology: https://510kreport.com/methodology