Koios Medical

GUDID 00860002545707

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.

KOIOS MEDICAL, INC.

Ultrasound imaging system application software

• Primary Device ID: 00860002545707
• NIH Device Record Key: 1ed33397-49ba-4020-b9b8-207700f168f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Koios Medical
• Version Model Number: 2.x
• Company DUNS: 093725663
• Company Name: KOIOS MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 732-529-5755
• Email: support@koiosmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860002545707 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190442

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-31
• Device Publish Date: 2020-03-23

On-Brand Devices [Koios Medical]

• 08600025457074: The Koios DS Breast system is designed to assist qualified interpreting physicians in analyzing
• 00860002545707: The Koios DS Breast system is designed to assist qualified interpreting physicians in analyzing