Supported acquisition environment
Scanner manufacturers: All
exact submission · checked 2026-09-01Confirm currently supported software versions, protocols, and site-specific acquisition configurations.
FDA-cleared profile
Koios DS
Koios Medical, Inc.
Authorized purpose: Koios DS is an artificial intelligence (AI)/machine learning (ML)-based computer-aided diagnosis (CADx) software device intended for use as an adjunct to diagnostic ultrasound examinations of lesions or nodules suspicious for breast or thyroid cancer. Koios DS allows the user to select or confirm regions of interest (ROIs) within an image representing a single lesion or nodule to be analyzed. The software then automatically characterizes the selected image data to generate an AI/ML-derived cancer risk assessment and selects applicable lexicon-based descriptors designed to improve overall diagnostic accuracy as well as reduce interpreting physician variability. Koios DS 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 DS software is designed to assist trained interpreting physicians in analyzing the breast ultrasound images of adult (>= 22 years) female patients with soft tissue breast lesions and/or thyroid ultrasounds of all adult (>= 22 years) patients with thyroid nodules suspicious for cancer. When utilized by an interpreting physician who has completed the prescribed training, this device provides information that may be useful in recommending appropriate clinical management. Limitations: Patient management decisions should not be made solely on the results of the Koios DS analysis. Koios DS software is not to be used for the evaluation of normal tissue, on sites of post-surgical excision, or images with doppler, elastography, or other overlays present in them. Koios DS software is not intended for use on portable handheld devices (e.g. smartphones or tablets) or as a primary diagnostic viewer of mammography images. The software does not predict the presence of the thyroid nodule margin descriptor, extra-thyroidal extension. In the event that this condition is present, the user may select this category manually from the margin descriptor list.
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.
Product overview
Start with the essentials
Authorized purpose: Koios DS is an artificial intelligence (AI)/machine learning (ML)-based computer-aided diagnosis (CADx) software device intended for use as an adjunct to diagnostic ultrasound examinations of lesions or nodules suspicious for breast or thyroid cancer. Koios DS allows the user to select or confirm regions of interest (ROIs) within an image representing a single lesion or nodule to be analyzed. The software then automatically characterizes the selected image data to generate an AI/ML-derived cancer risk assessment and selects applicable lexicon-based descriptors designed to improve overall diagnostic accuracy as well as reduce interpreting physician variability. Koios DS 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 DS software is designed to assist trained interpreting physicians in analyzing the breast ultrasound images of adult (>= 22 years) female patients with soft tissue breast lesions and/or thyroid ultrasounds of all adult (>= 22 years) patients with thyroid nodules suspicious for cancer. When utilized by an interpreting physician who has completed the prescribed training, this device provides information that may be useful in recommending appropriate clinical management. Limitations: Patient management decisions should not be made solely on the results of the Koios DS analysis. Koios DS software is not to be used for the evaluation of normal tissue, on sites of post-surgical excision, or images with doppler, elastography, or other overlays present in them. Koios DS software is not intended for use on portable handheld devices (e.g. smartphones or tablets) or as a primary diagnostic viewer of mammography images. The software does not predict the presence of the thyroid nodule margin descriptor, extra-thyroidal extension. In the event that this condition is present, the user may select this category manually from the margin descriptor list.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Koios DS is an artificial intelligence (AI)/machine learning (ML)-based computer-aided diagnosis (CADx) software device intended for use as an adjunct to diagnostic ultrasound examinations of lesions or nodules suspicious for breast or thyroid cancer. Koios DS allows the user to select or confirm regions of interest (ROIs) within an image representing a single lesion or nodule to be analyzed. The software then automatically characterizes the selected image data to generate an AI/ML-derived cancer risk assessment and selects applicable lexicon-based descriptors designed to improve overall diagnostic accuracy as well as reduce interpreting physician variability. Koios DS 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 DS software is designed to assist trained interpreting physicians in analyzing the breast ultrasound images of adult (>= 22 years) female patients with soft tissue breast lesions and/or thyroid ultrasounds of all adult (>= 22 years) patients with thyroid nodules suspicious for cancer. When utilized by an interpreting physician who has completed the prescribed training, this device provides information that may be useful in recommending appropriate clinical management. Limitations: Patient management decisions should not be made solely on the results of the Koios DS analysis. Koios DS software is not to be used for the evaluation of normal tissue, on sites of post-surgical excision, or images with doppler, elastography, or other overlays present in them. Koios DS software is not intended for use on portable handheld devices (e.g. smartphones or tablets) or as a primary diagnostic viewer of mammography images. The software does not predict the presence of the thyroid nodule margin descriptor, extra-thyroidal extension. In the event that this condition is present, the user may select this category manually from the margin descriptor list.
- Which images or clinical context are in scope? Modality: Ultrasound Anatomy or clinical context: Breast Input: Medical images provided in a DICOM format; selected breast or thyroid ultrasound images are processed after the user selects or confirms regions of interest.
- Who uses it? Intended users: Physician
- What does the software produce? Output: Koios DS Breast provides categorical and continuous outputs aligned to BI-RADS and U1-U5 with auto-classified shape and orientation. Koios DS Thyroid automatically classifies thyroid nodules with output aligned to TI-RADS or ATA, generates user-modifiable nodule descriptors, and provides a direct image-derived cancer risk assessment translated into an optional lexicon-specific modifier.
- What is its most important limitation? Key limitation: Patient management decisions should not be made solely on the results of the Koios DS analysis. Koios DS is not for normal tissue, post-surgical excision sites, or images with doppler, elastography, or other overlays; it is not intended for portable handheld devices or as a primary diagnostic viewer of mammography images; and it does not predict the thyroid nodule margin descriptor extra-thyroidal extension.
Clinical takeaway
Clinical role: Koios DS is an artificial intelligence (AI)/machine learning (ML)-based computer-aided diagnosis (CADx) software device intended for use as an adjunct to diagnostic ultrasound examinations of lesions or nodules suspicious for breast or thyroid cancer. Koios DS allows the user to select or confirm regions of interest (ROIs) within an image representing a single lesion or nodule to be analyzed. The software then automatically characterizes the selected image data to generate an AI/ML-derived cancer risk assessment and selects applicable lexicon-based descriptors designed to improve overall diagnostic accuracy as well as reduce interpreting physician variability. Koios DS 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 DS software is designed to assist trained interpreting physicians in analyzing the breast ultrasound images of adult (>= 22 years) female patients with soft tissue breast lesions and/or thyroid ultrasounds of all adult (>= 22 years) patients with thyroid nodules suspicious for cancer. When utilized by an interpreting physician who has completed the prescribed training, this device provides information that may be useful in recommending appropriate clinical management. Limitations: Patient management decisions should not be made solely on the results of the Koios DS analysis. Koios DS software is not to be used for the evaluation of normal tissue, on sites of post-surgical excision, or images with doppler, elastography, or other overlays present in them. Koios DS software is not intended for use on portable handheld devices (e.g. smartphones or tablets) or as a primary diagnostic viewer of mammography images. The software does not predict the presence of the thyroid nodule margin descriptor, extra-thyroidal extension. In the event that this condition is present, the user may select this category manually from the margin descriptor list.
Evidence takeaway
Evidence from the reviewed source record: The breast and thyroid engine validation sets are composed of 900 lesions from 900 different patients and 650 lesions from 650 different patients, respectively, and each was set aside from the systems' training data. The number of interpreting physicians utilized in both studies was 15 readers.
Clinical details
What this tool is for
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
- Exact purpose
- Koios DS is an artificial intelligence (AI)/machine learning (ML)-based computer-aided diagnosis (CADx) software device intended for use as an adjunct to diagnostic ultrasound examinations of lesions or nodules suspicious for breast or thyroid cancer. Koios DS allows the user to select or confirm regions of interest (ROIs) within an image representing a single lesion or nodule to be analyzed. The software then automatically characterizes the selected image data to generate an AI/ML-derived cancer risk assessment and selects applicable lexicon-based descriptors designed to improve overall diagnostic accuracy as well as reduce interpreting physician variability. Koios DS 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 DS software is designed to assist trained interpreting physicians in analyzing the breast ultrasound images of adult (>= 22 years) female patients with soft tissue breast lesions and/or thyroid ultrasounds of all adult (>= 22 years) patients with thyroid nodules suspicious for cancer. When utilized by an interpreting physician who has completed the prescribed training, this device provides information that may be useful in recommending appropriate clinical management. Limitations: Patient management decisions should not be made solely on the results of the Koios DS analysis. Koios DS software is not to be used for the evaluation of normal tissue, on sites of post-surgical excision, or images with doppler, elastography, or other overlays present in them. Koios DS software is not intended for use on portable handheld devices (e.g. smartphones or tablets) or as a primary diagnostic viewer of mammography images. The software does not predict the presence of the thyroid nodule margin descriptor, extra-thyroidal extension. In the event that this condition is present, the user may select this category manually from the margin descriptor list.
Clinical-use display mirrors the exact FDA-supported purpose reconciled from the decision-summary packet.
- Intended users
- Physician
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
- Care setting and population
- Adult
Patient-population text reported in the exact-submission ACR model card; institutional setting may still require vendor confirmation.
- Workflow role
- Measurement or quantification
Conservative normalization of explicit wording in an exact-submission source.
- Required input
- Medical images provided in a DICOM format; selected breast or thyroid ultrasound images are processed after the user selects or confirms regions of interest.
The packet states DICOM medical-image input and user-selected or confirmed regions for breast or thyroid ultrasound; the current value is incomplete.
- Output and human action
- Koios DS Breast provides categorical and continuous outputs aligned to BI-RADS and U1-U5 with auto-classified shape and orientation. Koios DS Thyroid automatically classifies thyroid nodules with output aligned to TI-RADS or ATA, generates user-modifiable nodule descriptors, and provides a direct image-derived cancer risk assessment translated into an optional lexicon-specific modifier.
The exact packet describes both breast and thyroid outputs; the current value covers only the thyroid output and is sourced from a non-FDA model card.
- Limitations
- Patient management decisions should not be made solely on the results of the Koios DS analysis. Koios DS is not for normal tissue, post-surgical excision sites, or images with doppler, elastography, or other overlays; it is not intended for portable handheld devices or as a primary diagnostic viewer of mammography images; and it does not predict the thyroid nodule margin descriptor extra-thyroidal extension.
The current limitations value only says 'Scanner manufacturers: All'; this replacement uses the packet's explicit labeled limitations.
Regulatory identity
FDA record and catalog context
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
- FDA submission
- K212616
- Modality
- Ultrasound
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
- Anatomy
- Breast
The exact indications cover lesions or nodules suspicious for breast or thyroid cancer; the current anatomy value retains only breast. Controlled directory display reconciled from exact FDA wording: Breast and thyroid. -> Breast.
- Clearance type
- 510(k)
- Decision date
- 2021-12-16
- FDA status
- FDA-cleared
Implementation
Questions for IT, informatics, and operations
Use these fields to structure a vendor demo, security review, and implementation estimate.
- Integration
- Standards-based DICOM/PACS integration was identified in the FDA submission materials; compatibility with a specific PACS, RIS, EHR, or orchestrator requires confirmation.
Normalized from the prior exact-submission review. Confirm interface versions and local compatibility during technical evaluation.
- Deployment and data flow
- On-premise
Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.
- Security and privacy
- Vendor documentation pending
Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Training and support
- Vendor documentation pending
Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Monitoring and change control
- Vendor documentation pending
Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
ACR exact-submission catalog context
ACR AI Central provides an exact-submission model card for Koios DS; FDA labeling remains controlling for clinical use, limitations, and performance.
exact submission · checked 2026-09-08Evidence
Performance evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version. Candidate literature without exact product and version linkage is not shown as product evidence.
- Evidence summary
- The breast and thyroid engine validation sets are composed of 900 lesions from 900 different patients and 650 lesions from 650 different patients, respectively, and each was set aside from the systems' training data. The number of interpreting physicians utilized in both studies was 15 readers.
The exact packet supports these validation-set and reader facts; the current reader-study metadata includes an unsupported null reference-standard field and does not state the packet's validation description.
- Reported sensitivity
- 5%; 92.9%; 0.511%
Values reported in the exact-submission materials. Consult the linked source for endpoint, threshold, population, and confidence interval before comparison.
- Reported specificity
- 24%; 18.741%
Values reported in the exact-submission materials. Consult the linked source for endpoint, threshold, population, and confidence interval before comparison.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
Koios DS- Thyroid regulatory performance study summary
- DesignReader Study
- PopulationAdult
- Scopeexact submission
- Tested versionExact product version not reported; regulatory study summarized for FDA submission K212616
- IndependenceIndependence not established
K212616
ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.
Costs and setup
Budget and ongoing governance
These are common procurement questions; unknown values remain visible until a source supports them.
- Pricing and total cost
- Vendor documentation pending
No public price or quote for the exact K212616 configuration was established in this review.
- Reimbursement and coding
- Not established in reviewed sources
No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.
Safety and lifecycle
Postmarket record
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
- Postmarket safety review
- The exact-identifier FDA recall query returned no native recall record for K212616. This limited result does not establish absence of recalls or other safety information and does not cover later versions, family records, MAUDE reports, corrections, or field notices.
Buyer worksheet
Open questions to take to the vendor
- Verify security and privacy controls: Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Verify training: Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Verify pricing and total cost: No public price or quote for the exact K212616 configuration was established in this review.
- Verify reimbursement and coding relevance: No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.
- Verify local validation and lifecycle monitoring: Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
Research record
What has been checked
This audit distinguishes completed source review from fields that have not yet been researched.
Exact FDA record reviewedStatus
2026-09-20Last searched
28Fields reviewed
10Source classes checked
14Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads
The refreshed discovery snapshot contains 14 PubMed and 0 ClinicalTrials.gov candidate records. Discovery metadata alone does not establish exact tested-product, version, population, and endpoint applicability, so all candidates remain quarantined and none was promoted. The current discovery snapshot contains 14 PubMed and 0 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.
Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.
Source classes: fda ai list, fda decision summary, acr ai central product, fda device recall, literature index, trial registry, fda decision summary packet, pubmed, clinical trials, openfda device recall
Sources & history
How this profile was documented
Open the ledger for source dates, scope, and research-record updates.
View source ledger and history
Source ledger
-
FDA K212616: Koios DS
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation, purpose, intendedUsers, input, output, limitations, evidenceSummary
-
Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
-
Koios DS- Thyroid model card (K212616)
Scope: intendedUsers, careSetting, output, limitations, evidenceSummary, anatomy, evidenceStudies, implementationCapabilities
-
PubMed biomedical literature index
Scope: evidenceDiscovery
-
ClinicalTrials.gov study registry
Scope: evidenceDiscovery, studyStatus
-
openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
-
openFDA exact recall query for K212616
Scope: postmarketSafety
Research history
-
K212616 FDA decision
Regulatory record
510(k)
-
Source-review record updated
Research record
fda record reviewed
-
Reader overview source-reviewed
Editorial review
Source-reviewed editorial overlay
Alternatives
Related tools to compare
FDA-cleared K242130
Koios DS
Koios Medical, Inc.
Koios Decision Support (DS) is an artificial intelligence (AI)/machine learning (ML)-based computer-aided diagnosis (CADx) software device intended for use as an adjunct to...
- Modality
- Ultrasound
- Anatomy
- Breast
- Decision
- 2024-11-15
FDA-cleared K161959
ClearView cCAD
ClearView Diagnostics Inc.
ClearView cCAD is a software application designed to assist skilled physicians in analyzing breast ultrasound images. It automatically classifies shape and orientation...
- Modality
- Ultrasound
- Anatomy
- Breast
- Decision
- 2016-12-28
FDA-cleared K251368
FETOLY
Diagnoly
FETOLY analyzes fetal ultrasound images and sequences to detect labeled fetal brain and heart views, assess image completeness or quality, and provide fetal biometric measurements...
- Modality
- Ultrasound
- Anatomy
- Fetal heart and fetal brain
- Decision
- 2025-09-12
FDA-cleared K242594
DEEPECHO
DeepEcho
Detect standard fetal biometry views and assist fetal biometry measurements during prenatal ultrasound acquisition and interpretation.
- Modality
- Ultrasound
- Anatomy
- Fetal biometry views and structures: cephalic/head, abdomen, and femur
- Decision
- 2025-05-23