Koios Medical

GUDID 08600025457074

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.

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Primary Device ID08600025457074
NIH Device Record Key14bb85eb-cbb3-409e-8b9e-80c1336aad6b
Commercial Distribution StatusIn Commercial Distribution
Brand NameKoios Medical
Version Model Number2.x
Company DUNS093725663
Company NameKOIOS MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone732-529-5755
Emailsupport@koiosmedical.com
Phone732-529-5755
Emailsupport@koiosmedical.com
Phone732-529-5755
Emailsupport@koiosmedical.com
Phone732-529-5755
Emailsupport@koiosmedical.com
Phone732-529-5755
Emailsupport@koiosmedical.com
Phone732-529-5755
Emailsupport@koiosmedical.com
Phone732-529-5755
Emailsupport@koiosmedical.com
Phone732-529-5755
Emailsupport@koiosmedical.com
Phone732-529-5755
Emailsupport@koiosmedical.com
Phone732-529-5755
Emailsupport@koiosmedical.com
Phone732-529-5755
Emailsupport@koiosmedical.com
Phone732-529-5755
Emailsupport@koiosmedical.com
Phone732-529-5755
Emailsupport@koiosmedical.com
Phone732-529-5755
Emailsupport@koiosmedical.com
Phone732-529-5755
Emailsupport@koiosmedical.com
Phone732-529-5755
Emailsupport@koiosmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108600025457074 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-26
Device Publish Date2019-11-18

On-Brand Devices [Koios Medical]

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