Koios DS

Primary DI
00860002545714
Brand
Koios DS
Company
KOIOS MEDICAL, INC.
Model
3.x
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 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.
Published
2022-01-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
POKComputer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
QIHAutomated Radiological Image Processing Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
POKComputer-Assisted Diagnostic Software For Lesions Suspicious For CancerRadiology2
QIHAutomated Radiological Image Processing SoftwareRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212616000
K242130000
K253884000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212616000Koios DSKoios Medical, Inc.2021-12-16POK
K242130000Koios DSKoios Medical, Inc.2024-11-15POK
K253884000Koios DS (3.8)Koios Medical, Inc.2026-07-02POK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860002545714PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860002545714008600025457148600025457140860002545714

GMDN Terms#

Term, Definition table
TermDefinition
Breast ultrasound clinical assessment support softwareA software program intended to display and analyse/process ultrasound images of the breast, to support a healthcare provider with clinical assessment (e.g., diagnosis, triage) of breast cancer. It is not dedicated to treatment planning and does not incorporate adaptive/dynamic machine learning (ML) models.

Contacts#

Phone, Email table
PhoneEmail
7325295755support@koiosmedical.com

Regulatory Flags#

DUNS number
093725663
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860002545707Koios Medical2.x2020-03-23
08600025457074Koios Medical2.x2019-11-18

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