# K212616: Koios DS

- Pathway: 510(k) (Traditional)
- Applicant: Koios Medical, Inc.
- Decided: Dec 16, 2021 after 120 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: 8 generations back to K913770 (1991). 15 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190442: Koios DS for Breast, Koios Medical, Inc. (2019) Summary page 5.

## Most influential descendants
- K243614: Sonio Suspect (2025), 1 descendant of its own
- K242130: Koios DS (2024), 1 descendant of its own
- K253884: Koios DS (3.8) (2026), 0 descendants of its own
- K261519: Sonio Suspect (2026), 0 descendants of its own

## Indications for use
Koios DS is an artificial intelligence (Al)/machine learning (ML)-based computer-aided diagnosis (CADx) software device intended for use as an adjunct to diagnostic ultrasound examinations of lesions or nodules suspicious for breast or thyroid cancer. Koios DS allows the user to select or confirm regions of interest (ROIs) within an image representing a single lesion or nodule to be analyzed. The software then automatically characterizes the selected image data to generate an AI/ML-derived cancer risk assessment and selects applicable lexicon-based descriptors designed to improve overall diagnostic accuracy as well as reduce interpreting physician variability. Koios DS 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. Koios DS software is designed to assist trained interpreting physicians in analyzing the breast ultrasound images of adult (>= 22 years) female patients with soft tissue breast lesions and/or thyroid ultrasounds of all adult (>= 22 years) patients with thyroid nodules suspicious for cancer. When utilized by an interpreting physician who has completed the prescribed training, this device provides information that may be useful in recommending appropriate clinical management. Limitations: » Patient management decisions should not be made solely on the results of the Koios DS analysis. » Koios DS software is not to be used for the evaluation of normal tissue, on sites of post-surgical excision, or images with doppler, elastography, or other overlays present in them. » Koios DS software is not intended for use on portable handheld devices (e.g. smartphones or tablets) or as a primary diagnostic viewer of mammography images. * The software does not predict the presence of the thyroid nodule margin descriptor, extra-thyroidal extension. In the event that this condition is present, the user may select this category manually from the margin descriptor list.

Source page: https://510kreport.com/device/K212616
Methodology: https://510kreport.com/methodology