koiosmedical.comKoios DS
Koios Medical, Inc.
Koios Medical, Inc.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3010119782 | 3010119782 | Koios Medical, Inc. | 1 | N | 2026-01-01 | 242 West 38th Street 14th Floor New York NY US 10018 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00860002545707 | Koios Medical - The Koios DS Breast system is designed to assist qualified interpreting physicians in analyzing breast ultrasound images by providing a system generated categorical output that aligns with or exceeds the sensitivity and specificity of radiologist chosen BI-RADS categorizations using computer vision and machine learning techniques.Koios DS 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. | 732-529-5755 | support@koiosmedical.com |
| 00860002545714 | Koios DS - Koios Decision Support (DS) is a software application designed to assist trained interpreting physicians in analyzing breast and thyroid ultrasound images. The software device is a web application that is deployed to a web server and accessed by a user through a compatible client. Once logged in and granted access to the Koios DS application, the user examines selected breast or thyroid ultrasound DICOM images. The user selects Regions of Interest (ROIs) of orthogonal views of a breast lesion or thyroid nodule for processing by Koios DS. The ROI(s) are transmitted electronically to the Koios DS server for image processing and the results are returned to the user for review. | 7325295755 | support@koiosmedical.com |
| 08600025457074 | Koios Medical - The Koios DS Breast system is designed to assist qualified interpreting physicians in analyzing breast ultrasound images by providing a system generated categorical output that aligns with or exceeds the sensitivity and specificity of radiologist chosen BI-RADS categorizations using computer vision and machine learning techniques. Koios DS 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. | 732-529-5755 | support@koiosmedical.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 206649 | 1826916758 | K253884 | Koios DS (3.8) | POK | 2026-07-02 |
| 206649 | 1144262879 | K242130 | Koios DS | POK | 2024-11-15 |
| 206649 | 1135506312 | K212616 | Koios DS | POK | 2021-12-16 |
| 206649 | 1582755461 | K190442 | Koios DS for Breast | POK | 2019-07-03 |
| 206649 | 1876420947 | K161959 | ClearView cCAD | LLZ | 2016-12-28 |
Product Codes Associated With Registrations#
PMN#
Koios DS
Koios Medical, Inc.
Koios DS For Breast
Koios Medical, Inc.
GUDID#
Koios DS - Koios Decision Support (DS) is a software application designed to assist trained interpreting physicians in analyzing breast and thyroid ultrasound images. The software device is a web application that is deployed to a web server and accessed by a user through a compatible client. Once logged in and granted access to the Koios DS application, the user examines selected breast or thyroid ultrasound DICOM images. The user selects Regions of Interest (ROIs) of orthogonal views of a breast lesion or thyroid nodule for processing by Koios DS. The ROI(s) are transmitted electronically to the Koios DS server for image processing and the results are returned to the user for review.
2022-01-12
Koios Medical - The Koios DS Breast system is designed to assist qualified interpreting physicians in analyzing breast ultrasound images by providing a system generated categorical output that aligns with or exceeds the sensitivity and specificity of radiologist chosen BI-RADS categorizations using computer vision and machine learning techniques.Koios DS 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.
2020-03-23
Koios Medical - The Koios DS Breast system is designed to assist qualified interpreting physicians in analyzing breast ultrasound images by providing a system generated categorical output that aligns with or exceeds the sensitivity and specificity of radiologist chosen BI-RADS categorizations using computer vision and machine learning techniques. Koios DS 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.
2019-11-18