# K131885: Senographe Essential, Premium View I (Pvi)

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems SCS
- Decided: Sep 26, 2013 after 93 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: 2 generations back to P990066 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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.
- K110798: Senographe DS, Senographe Essential, General Electric Company (2011) Summary page 1.

## Indications for use
The Senographe Essential FFDM systems generate digital mammographic images that can be used for screening and in the diagnosis of breast cancer. The 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 thin breasts, very dense breasts. or implants that currently require multiple adjustments of WW and WL to review. eContrast accommodates different customer display preferences in screening and diagnosis, with 5 different levels, while keeping the PVi option for implants. eContrast postprocessing is also available for stereo images.

Source page: https://510kreport.com/device/K131885
Methodology: https://510kreport.com/methodology