Koios DS
GUDID 00860002545714
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.
KOIOS MEDICAL, INC.
Ultrasound imaging system application software| Primary Device ID | 00860002545714 |
| NIH Device Record Key | 790acf4b-735f-44f0-be60-a08567523dfd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Koios DS |
| Version Model Number | 3.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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860002545714 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K212616
FDA Product Code
| POK | Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer |
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 | 2022-01-20 |
| Device Publish Date | 2022-01-12 |
Devices Manufactured by KOIOS MEDICAL, INC.
| 00860002545714 - Koios DS | 2022-01-20Koios 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. |
| 00860002545714 - Koios DS | 2022-01-20 Koios Decision Support (DS) is a software application designed to assist trained interpreting physicians in analyzing breast and |
| 00860002545707 - Koios Medical | 2020-03-31 The Koios DS Breast system is designed to assist qualified interpreting physicians in analyzing breast ultrasound images by prov |
| 08600025457074 - Koios Medical | 2019-11-26 The Koios DS Breast system is designed to assist qualified interpreting physicians in analyzing breast ultrasound images by prov |
Trademark Results [Koios DS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 KOIOS DS 88421199 not registered Live/Pending |
KOIOS MEDICAL, INC 2019-05-08 |
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