# K973411: Digmi-2000 (Gsi Internal Reference)/LD2800 (Marketing Name)

- Pathway: 510(k) (Traditional)
- Applicant: General Scanning, Inc.
- Decided: Dec 4, 1997 after 86 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: 1 generation back to K901423 (1990). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K901423: Digital Image Scanner, Model Dis-1000, Lumisys, Inc. (1990) Summary page 1.
- K933830: Konica LD-4500 Laser Digitizer, Konica Medical Corp. (1993)
- (no number) Lumiscan 85LF: named in the summary without a submission number
- (no number) Nishimoto Sangyo ED-2000: named in the summary without a submission number
- (no number) Nishimoto Sangyo ED-3500: named in the summary without a submission number

## Most influential descendants
- K980565: LD2000 Series (1998), 0 descendants of its own

## Indications for use
The General Scanning model LD2800 laser film digitizer is intended to create copies of medical images stored on film when connected to a laser imager. It is intended for use in making copies of conventional x-ray films as well as films produced by imagers that fall in the ranges specified for size and optical density range detailed in the specifications.

Source page: https://510kreport.com/device/K973411
Methodology: https://510kreport.com/methodology