# K231130: TumorSight Viz

- Pathway: 510(k) (Traditional)
- Applicant: SimBioSys, Inc.
- Decided: Dec 26, 2023 after 250 days
- Product code: QIH (Automated Radiological Image Processing Software)
- 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: 11 generations back to K913770 (1991). 75 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 78 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092954: Cadstream Version 5, Confirma, Inc. (2009) Summary page 4.

## Most influential descendants
- K243189: TumorSight Viz (2024), 1 descendant of its own
- K251766: TumorSight Viz (2025), 0 descendants of its own

## Indications for use
TumorSight Viz is intended to be used in the visualization and analysis of breast magnetic resonance imaging (MRI) studies for patients with biopsy proven early-stage or locally advanced breast cancer. TumorSight Viz supports evaluation of dynamic MR data acquired from breast studies during contrast administration. TumorSight Viz performs processing functions (such as image registration, subtractions, measurements, 3D renderings, and reformats). TumorSight Viz also includes user-configurable features for visualizing and analyzing findings in breast MRI studies. Patient management decisions should not be made based solely on the results of TumorSight Viz.

Source page: https://510kreport.com/device/K231130
Methodology: https://510kreport.com/methodology