# K190442: Koios DS for Breast

- Pathway: 510(k) (Traditional)
- Applicant: Koios Medical, Inc.
- Decided: Jul 3, 2019 after 128 days
- Product code: POK (Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer)
- Device class: 2
- Regulation: 21 CFR 892.2060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K913770 (1991). 14 ancestors in all.
12 later devices descend from it; 2 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN170022: QuantX, Quantitative Insights, Inc. (2017) Summary page 4.
- K161959: ClearView cCAD, Clearview Diagnostics, Inc. (2016) Summary page 5.

## Most influential descendants
- K201555: EchoGo Pro (2020), 6 descendants of its own
- K212616: Koios DS (2021), 4 descendants of its own
- K242342: Fetal EchoScan (2024), 2 descendants of its own
- K251071: Fetal EchoScan (v1.1) (2025), 1 descendant of its own
- K243614: Sonio Suspect (2025), 1 descendant of its own

## Indications for use
Koios Decision Support (DS) for Breast is a software application designed to assist trained interpreting physicians in analyzing the breast ultrasound images of patients with soft tissue breast lesions who are being referred for further diagnostic ultrasound examination. Koios DS for Breast is a machine learning-based decision support system, indicated as an adjunct to diagnostic ultrasound for breast cancer. Koios DS for Breast automatically classifies user-selected region(s) of interest (ROIs) containing a breast lesion into four BI-RADS-aligned categories (Benign, Probably Benign, Suspicious, Probably Malignant), and displays a continuous graphical confidence level indicator of where the lesion falls across all categories. Koios DS for Breast also automatically classifies lesion shape and orientation according to BI-RADS descriptors. The software requires a user to select up to two ROIs, from up to two orthogonal views, that represent a single lesion to be selected and processed. When utilized by an interpreting physician who has completed the prescribed training, this device provides information that may be useful in rendering an accurate diagnosis. Patient management decisions should not be made solely on the results of the Koios DS for Breast analysis. This device is intended to help trained interpreting physicians improve their overall accuracy as well as reduce inter- and intra-operator variability. Koios DS for Breast may also be used as an image viewer of multi-modality digital images, including ultrasound and mammography. The software includes tools that allow users to adjust, measure and document images, and output into a structured report. Limitations: Koios DS for Breast is not to be used on sites of post-surgical excision, or images with doppler, elastography, or other overlays present in them. Koios DS for Breast is not intended for the primary interpretation of digital mammography images. Koios DS for Breast is not intended for use on mobile devices.

Source page: https://510kreport.com/device/K190442
Methodology: https://510kreport.com/methodology