Home GUDID 00860002545714 Koios DS
Primary DI 00860002545714
Brand Koios DS
Company KOIOS MEDICAL, INC.
Model 3.x
Device description 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.
Published 2022-01-12
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false
Product Codes# Code, Name table Code Name POK Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer QIH Automated Radiological Image Processing Software
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class POK Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer Radiology 2 QIH Automated Radiological Image Processing Software Radiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00860002545714 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00860002545714 00860002545714 860002545714 0860002545714
GMDN Terms# Term, Definition table Term Definition Breast ultrasound clinical assessment support software A software program intended to display and analyse/process ultrasound images of the breast, to support a healthcare provider with clinical assessment (e.g., diagnosis, triage) of breast cancer. It is not dedicated to treatment planning and does not incorporate adaptive/dynamic machine learning (ML) models.
Regulatory Flags# DUNS number 093725663 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00860002545707 Koios Medical 2.x 2020-03-23 08600025457074 Koios Medical 2.x 2019-11-18
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