# K123420: Syngo, Breast Care

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Feb 1, 2013 after 87 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K033712 (2003). 6 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042868: Mammoreport Softcopy Workstation, Siemens Medical Solutions USA, Inc. (2005) Summary page 2.

## Most influential descendants
- K212621: MAMMOVISTA B.smart (2021), 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

## Recalls of this device
- Jun 6, 2016 · Class II · Z-2107-2016: Software issues. Siemens is voluntarily initiating a recall after they became aware of the following system behavior: 1) At times, the view and laterality marker is overlaid by patient demographic i

## Indications for use
syngo.Breast Care is a dedicated softcopy review environment for both screening and diagnostic mammography as well as digital breast tomosynthesis. Its user interface and workflow have been optimized to support experienced mammography and tomosynthesis reviewers in both screening and diagnostic reading. Efficiency and reading quality are supported by various specialized features. syngo.Breast Care provides visualization and image enhancement tools to aid a qualified radiologist in the review of digital mammography images and digital breast tomosynthesis datasets. The radiologist is responsible for making the diagnosis of the images presented.

Source page: https://510kreport.com/device/K123420
Methodology: https://510kreport.com/methodology