# K110798: Senographe DS, Senographe Essential

- Pathway: 510(k) (Traditional)
- Applicant: General Electric Company
- Decided: Dec 22, 2011 after 275 days
- Product code: MUE (Full Field Digital, System, X-Ray, Mammographic)
- Device class: 2
- Regulation: 21 CFR 892.1715
- 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 P990066 (2000). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P990066: GE Healthcare Senographe Full Field Digital Mammography System, GE Healthcare (2000) Summary page 1.

## Most influential descendants
- K220073: RMF-2000 (2023), 1 descendant of its own
- K254092: Bellalun 2D (VDMS-1000S) (2026), 0 descendants of its own
- K131885: Senographe Essential, Premium View I (Pvi) (2013), 0 descendants of its own

## Indications for use
The Senographe DS and Senographe Essential FFDM systems generate digital mammographic images that can be used for screening and in the diagnosis of breast cancer. The Senographe DS and Senographe Essential FFDM systems are intended to be used in the same clinical applications as traditional film-based mammographic systems. Premium View is an image-processing algorithm, which increases the visibility of breast structures. The main advantage is to provide a single breast image, where the contrast in the fatty tissues is similar to that obtained by setting WW (window width) and WL (window level) for optimum visualization of fatty tissues, and the contrast in the fibro-glandular tissue is similar to that obtained by setting WW and WL for optimal visualization of fibro-glandular tissues. PVi is an option that can simplify' the presentation of mammographic images, improve workflow, and streamline the review process of images with very dark or bright areas by presenting the image with the WW and WL optimized for review with minimal need for the user to make adjustments for the various tissue areas. This could be especially useful with patients who have very dense breasts, or implants that currently require multiple adjustments of WW and WL to review.

Source page: https://510kreport.com/device/K110798
Methodology: https://510kreport.com/methodology