# K980565: LD2000 Series

- Pathway: 510(k) (Traditional)
- Applicant: General Scanning, Inc.
- Decided: Mar 19, 1998 after 34 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 K901423 (1990). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973411: Digmi-2000 (Gsi Internal Reference)/LD2800 (Marketing Name), General Scanning, Inc. (1997) Summary page 1.
- 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

## Indications for use
The General Scanning model LD2000 SERIES laser film digitizer is intended to convert medical images stored on film to digital data for copying, storage, and transmission. It is intended for use to digitize copies of conventional x-rays and films produced by imagers that fall in the ranges for size and optical density range detailed in the specifications. The digitizer utilizes laser light to scan the film, extracts the image data by measuring the transmitted light, converts it into digital form, and transmits the data over a digital link. The digitized information may then be transmitted to a Laser Imager for printed hardcopy or to a Work Station for use in Teleradiology (transmission of images) or PACS (Picture Archiving Communication Systems). The LD2000 SERIES contains the scanning laser and detection module, a film transport, and electronics to convert and transmit the image data and provide control and calibration.

Source page: https://510kreport.com/device/K980565
Methodology: https://510kreport.com/methodology