# K212621: MAMMOVISTA B.smart

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Nov 12, 2021 after 86 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 K033712 (2003). 7 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K123420: Syngo, Breast Care, Siemens Medical Solutions USA, Inc. (2013) Summary page 5.

## Most influential descendants
- 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
MAMMOVISTA B.smart 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. MAMMOVISTA B.smart provides visualization and image enhancement tools to aid a qualified radiologist in the review of digital mammography and digital breast tomosynthesis datasets, as well as other modalities of breast images.

Source page: https://510kreport.com/device/K212621
Methodology: https://510kreport.com/methodology