# K132684: Medws Software (Variants Medview, Meddiag, Medmammo)

- Pathway: 510(k) (Abbreviated)
- Applicant: Medecom Sarl
- Decided: May 23, 2014 after 268 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: 7 generations back to K913770 (1991). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103385: Securview DX Diagnostic Workstation, Hologic, Inc. (2011) Summary page 1.

## Indications for use
The MEDWS Software (MEDVIEWS, MEDDIAG, MEDMAMMO) is intended for selection, display, manipulation and media interchange of medical images, including mammograms. It can show images from different modalities and interfaces to various image storage and printing device using DICOM or similar interface standards. Lossy compressed mammographic image are not intended for diagnostic review. Mammographic images should only be viewed with a monitor cleared by FDA for viewing mammographic images. For primary diagnosis, post process DICOM for presentation images must be used. The MEDWS Software (MEDVIEWS, MEDDIAG, MEDMVAMMO) is typically used by trained professionals including but not limited to physicians, radiologists, nurses, medical technicians and assistants.

Source page: https://510kreport.com/device/K132684
Methodology: https://510kreport.com/methodology