# K980213: DI-2000

- Pathway: 510(k) (Traditional)
- Applicant: Lumisys, Inc.
- Decided: Mar 17, 1998 after 67 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 K952914 (1995). 5 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972191: Digitizer Director (HSC025-01), Howtek, Inc. (1997) Summary page 4.
- K963628: Imageshare Computed Radiography Acquisition Station and/or Software, Dejarnette Research Systems (1996) Summary page 4.
- K963594: Imageshare Secondary Capture Acquisition Station and/or Software (1000 Film Digitizer Acquisition Station), Dejarnette Research Systems (1996) Summary page 4.
- K970652: Mitra Imaging, Inc. Film Express Scanning Software, Mitra Imaging, Inc. (1997) Summary page 4.

## Most influential descendants
- K020243: Laserpro 16 (2002), 3 descendants of its own
- K052938: CR-PRO (2005), 2 descendants of its own
- K142718: Radlink GPS (2014), 1 descendant of its own
- K242161: Radlink GPS Pro Imaging (2025), 0 descendants of its own
- K012155: Kodak Radiation Oncology Software/ for Acr Systems (2001), 0 descendants of its own

## Indications for use
DI-2000 is intended to utilize a scanner and software interface to digitize either radiology film or computed radiography exposed phosphor plates. DI-2000 is a DICOM 3.0 compliant radiological digitization application. DI-2000 enables the user to autoarchive lossless or lossy compressed images locally or at a remote archive site. Supports DICOM 3.0 Query and Retrieve Service Class. Supports scanning of films or phosphor plates in batch mode prior to entering patient information. Once scanned, images can be sent to multiple destinations. Users: The DI-2000 will be located in a radiology department or clinic, or in a mobile radiology van. DI-2000 will support reading and digitizing exposed CR plates or radiology film. The expected users are as follows: Radiologists Radiology Technologists System Administrator within the radiology department

Source page: https://510kreport.com/device/K980213
Methodology: https://510kreport.com/methodology