# K170195: QuantX

- Pathway: 510(k) (Traditional)
- Applicant: Quantitative Insights, Inc.
- Decided: May 17, 2017 after 114 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: 11 generations back to K913770 (1991). 75 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 80 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081556: Cadstream, Version 5.0, Confirma, Inc. (2009) Summary page 4.
- K092954: Cadstream Version 5, Confirma, Inc. (2009) Summary page 4.

## Most influential descendants
- K210670: BU-CAD (2021), 3 descendants of its own
- K260086: CadAI-B Dx (2026), 0 descendants of its own
- K260303: See-Mode Augmented Reporting Tool, Breast (SMART-B) (2026), 0 descendants of its own
- K240697: See-Mode Augmented Reporting Tool, Thyroid (SMART-T) (2024), 0 descendants of its own

## Indications for use
QuantX is a quantitative image analysis software device used to assist radiologists in the assessment and characterization of breast abnormalities using MR image data. The software automatically registers images, and segments and analyzes user-selected regions of interest (ROI). QuantX extracts image data from the ROI to provide volumetric and surface area analysis. These imaging features are then displayed to the user in a dedicated analysis panel on the display monitor. When interpreted by a skilled physician, this device provides information that may be useful for screening and diagnosis. Patient management decisions should not be made based solely on the results of QuantX analysis. QuantX may also be used as an image viewer of multi-modality digital images, including ultrasound and mammography. The software also includes tools that allow users to measure and document images, and output in a structured report. Limitations: QuantX is not intended for primary interpretation of digital mammography images.

Source page: https://510kreport.com/device/K170195
Methodology: https://510kreport.com/methodology