# K143361: Mammo Workstation

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Mar 26, 2015 after 122 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: 8 generations back to K842308 (1984). 39 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123575: Mammoworkstation, Image Diagnost International GmbH (2013) Summary page 4.

## Most influential descendants
- K160937: Senolris (2016), 0 descendants of its own

## Indications for use
MammoWorkstation is designed to assist radiologists in conducting primary diagnostic review for diagnostic and screening mammography through flexible and interactive manipulation of multi-modality softcopy images. It provides image review, manipulation, analysis, post-processing and printing capabilities that support image management display needs in the medical environment. MammoWorkstation is designed to give easy and economic access to and display of multi-modality softcopy images, structured reports, and CAD results through interfaces to various image storage devices using DICOM or similar interface standards. It supports creation of structured reports according to the DICOM breast imaging report templates. MammoWorkstation supports teleradiology and teleconferencing providing access to multi-modality softcopy images and structured reports in multiple locations within and outside the hospital. Lossy compressed mammographic images must not be used for primary diagnostic interpretation unless approved for use in digital mammography. Display monitors used for primary diagnostic interpretation of mammographic images must be approved for use in digital mammography. All images sent to or imported in the Mammoworkstation must conform to regulatory requirements. Image quality must conform with applicable quality guidelines. All modalities must be certified for soft-copy reading.

Source page: https://510kreport.com/device/K143361
Methodology: https://510kreport.com/methodology