# K080351: Dexela Dex Top Mammography Workstation, Model Mamwkvi

- Pathway: 510(k) (Traditional)
- Applicant: Dexela, Ltd.
- Decided: Apr 22, 2008 after 71 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: 4 generations back to K913770 (1991). 5 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033400: Seno Advantage, Ge Medical Systems W-400 (2003) Summary page 1.

## Most influential descendants
- K091368: R2 Digitalnow HD (Digitalnow HD) (2009), 1 descendant of its own
- K123530: Mammography Prior Enhancement (Mpe) (2012), 0 descendants of its own

## Indications for use
The DexTop Mammography Workstation is a mammography review workstation software package, which provides very high performance viewing, processing and analysis of multimodality two and three dimensional, as well as planar, medical image data. The DexTop Workstation is designed to assist the radiologist in conducting screening and primary diagnosis through flexible, fast and efficient image hanging and processing of multimodality soft-copy images with special emphasis and optimization for mammography. Dexela DexTop Mammography Workstation will display the full fidelity DICOM image in a non-compressed format. Lossy compressed mammography images and digitized film screen images must not be used for the purpose of primary diagnosis. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 megapixel resolution and meets other technical specifications reviewed and accepted by the FDA When interpreted by a skilled physician, this software provides information that may be useful in screening and diagnosis. However, the final judgment must rely on the knowledge and skill of the physician. The device will display only DICOM "For Presentation" images for primary image diagnosis. The device does not perform any image processing (except simple manipulation such as gray scale changes by window level and window width) of the proprietary image processing algorithm of the FFDM manufacturers.

Source page: https://510kreport.com/device/K080351
Methodology: https://510kreport.com/methodology