Koios Medical

FDA UDI

Class II (US FDA UDI)

by Koios Medical, Inc.

Identity

Trade Name: Koios Medical FDA UDI
Generic Name: Ultrasound imaging system application software FDA UDI
Device Name: 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. FDA UDI
Model / Reference: 2.x FDA UDI
Description: 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. FDA UDI

Identifiers

Primary DI / UDI-DI: 00860002545707 FDA UDI
510(k) Number: K190442 FDA UDI
FDA Product Code: LLZ FDA UDI
POK FDA UDI
GMDN Term: Ultrasound imaging system application software FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.2050 FDA UDI
892.2060 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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Implantable

FDA UDI

Contains Latex

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Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

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Lot / Batch Number

Yes

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Serial Number

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Expiration Date

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Manufacturing Date

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Category: Ultrasound imaging system application software

Koios Medical by Koios Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Koios Medical, Inc.

Sources (1)

FDA UDI 1ed33397-49ba-4020-b9b8-207700f168f3 35 fields · synced May 30, 2026