# K063846: Eigen Dsa 2000

- Pathway: 510(k) (Special)
- Applicant: Eigen
- Decided: Jan 26, 2007 after 30 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- 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 K901956 (1990). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K901956: Digital 8 W/Other Numerical Suffixes (1-9, Etc.), Eigen (1990) Summary page 1.

## Most influential descendants
- K082341: DSA 2000EX (2008), 0 descendants of its own

## Indications for use
The Eigen DSA 2000 product is used in vascular imaging applications. During X-ray exposures, the DSA 2000 is used to acquire video images from the video display chain provided by the X-ray manufacturer's system. The images are stored in the DSA 2000 solid state memory, and written to the hard disk medium. Images are processed in real-time to provide increased image usability. The processing is primarily subtraction, but also includes window and level adjustments, as well as optional noise reduction, landscaping, and pixel shifting. The Eigen DSA 2000 device is used in X-ray cardiology and radiology labs to enhance diagnostic capabilities of radiologists and cardiologists, with minimal intervention required by users to perform basic capture, playback, and archiving functions.

Source page: https://510kreport.com/device/K063846
Methodology: https://510kreport.com/methodology