# K042868: Mammoreport Softcopy Workstation

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jan 6, 2005 after 80 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: 2 generations back to K033712 (2003). 5 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P030010: Siemens Mammomat Novationdr Full Field Digital Mammography System, Siemens Medical Solution (2004) Summary page 1.
- K040970: Leonardo, Siemens Medical Systems, Inc. (2004) Summary page 2.
- K040376: Sectra IDS5 Radiology Workstation; Sectra MPR Package; Sectra 3D Package, Sectra-Imtec AB (2004) Summary page 2.

## Most influential descendants
- K123420: Syngo, Breast Care (2013), 3 descendants of its own
- K212621: MAMMOVISTA B.smart (2021), 2 descendants of its own
- K052461: Syngo Imaging Version V20A (2005), 2 descendants of its own
- K223501: ViewFinder Software Version 1.1 (2023), 0 descendants of its own
- K223363: MAMMOVISTA B.smart (VB70) (2023), 0 descendants of its own

## Indications for use
The MammoReportPlus is a medical diagnostic workstation for viewing, manipulation, communication, reporting and storage of medical images and data on exchange media including mammography images. It interfaces to various image storage and printing devices using DICOM or similar interface standards. The MammoReportPlus used with FDA cleared monitors may be used by trained physicians for display, manipulation and interpretation of lossless compressed or non-compressed mammography images and diagnostic mammography, as well as any other DICOM multi-modality image. CAD markers created by FDA approved devices may be displayed. Trained professionals, including, but not limited to physicians, radiologists, nurses, medical technicians and assistants, typically use the MammoReportPlus.

Source page: https://510kreport.com/device/K042868
Methodology: https://510kreport.com/methodology