Koios Medical, Inc. radiology AI products

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FDA-cleared K242130

Koios DS

Koios Medical, Inc.

Authorized purpose: Koios Decision Support (DS) is an artificial intelligence (AI)/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/MLderived cancer risk assessment and selects applicable lexicon-based descriptors designed to improve overall diagnostic accuracy as well as reduce interpreting physician variability. Koios DS software 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.

Modality: Ultrasound
Anatomy: Breast
Decision: 2024-11-15

FDA-cleared K212616

Koios DS

Koios Medical, Inc.

Authorized purpose: Koios DS is an artificial intelligence (AI)/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.

Modality: Ultrasound
Anatomy: Breast
Decision: 2021-12-16

Breast imaging Detection and CADe Quantification and segmentation

FDA-cleared K190442

Koios DS for Breast

Koios Medical, Inc.

Authorized purpose: Adjunctive breast-cancer decision support during diagnostic ultrasound for patients referred for further diagnostic ultrasound; classifies a user-selected lesion ROI into four BI-RADS-aligned categories and assesses shape and orientation.

Modality: Mammography/DBT
Anatomy: Soft-tissue breast lesions.
Decision: 2019-07-03

Breast imaging