Koios DS

Basic Information

• Brand Name: Koios DS
• Primary DI: 00860002545714
• Version / Model: 3.x
• Company Name: KOIOS MEDICAL, INC.
• Labeler DUNS: 093725663
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-01-12
• Public Version: 1
• Public Version Date: 2022-01-20
• Public Version Status: New
• Public Device Record Key: 790acf4b-735f-44f0-be60-a08567523dfd

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 Microsoft IIS 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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
POK	Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer	Radiology	892.2060	2
QIH	Automated Radiological Image Processing Software	Radiology	892.2050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40873	Ultrasound imaging system application software	An individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a diagnostic ultrasound system configuration. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software programs or program packages must be combined with specific hardware or firmware configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860002545714	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K212616	000