Medical imaging and radiology
Aidoc
Clinical AI platform for radiology and enterprise imaging workflows.
Last updated: June 5, 2026
Back to directoryKoios DS Breast medical AI product profile
Smart ultrasound software that analyzes breast ultrasound images and supports physician risk assessment for suspicious lesions.
Medical imaging and radiology
Best fit
Breast ultrasound teams evaluating adjunctive CADx support while preserving trained physician interpretation and BI-RADS workflow responsibility.
- Primary use case
- AI-assisted risk assessment and computer-aided diagnosis support for breast ultrasound lesions
- Audience
- Breast imaging centers, diagnostic radiology groups, ultrasound clinics, and health systems using breast ultrasound
- Risk level
- High
- Pricing signal
- Enterprise and provider pricing; verify current module, thyroid/breast scope, billing workflow, and deployment terms.
- Official sources
- 4 official sources
Compare within workflow: Medical imaging and radiology · comparison shortlist · source index
Regulatory, privacy, evidence, and workflow lens
Product-specific review. These product-specific signals summarize what the cited sources imply before treating Koios DS Breast as safe for a local clinical, operational, or research workflow.
| Regulatory / FDA | Match K212616 or the relevant current clearance to the exact breast ultrasound workflow, patient group, lesion type, and trained interpreting-physician use. |
|---|---|
| Privacy | Review ultrasound image transfer, DICOM metadata handling, cloud or local processing, retention, user access, audit logs, and security documentation before sending clinical studies. |
| Evidence | Validate CADx performance on local ultrasound equipment, operator mix, lesion prevalence, benign/malignant balance, subgroup representation, and downstream biopsy decisions. |
| Workflow | Best used as adjunctive physician-reviewed ultrasound decision support, with explicit documentation of ROI selection, AI output review, BI-RADS reconciliation, and final clinician accountability. |
Where Koios DS Breast fits
Koios describes Koios DS Breast as FDA-cleared and CE-marked smart ultrasound software for breast cancer risk assessment; FDA K212616 materials describe Koios DS as an AI/ML CADx adjunct for diagnostic ultrasound examinations of suspicious breast lesions and thyroid nodules.
Not for: Screening mammography replacement, standalone breast cancer diagnosis, unsupported patient groups, or use outside the cleared ultrasound indication.
What to verify before using Koios DS Breast
- Whether Koios DS Breast, Koios DS, or another module/version matches the intended breast ultrasound workflow.
- FDA 510(k), CE mark, billable-procedure claims, patient age, lesion type, modality, and trained-user requirements.
- How regions of interest, risk output, report language, PACS integration, and physician acceptance or rejection are documented.
- Local performance across scanner models, lesion presentations, breast density, operator skill, false positives, false negatives, and biopsy/referral patterns.
Source links
Use these links to confirm current claims, terms, regulatory status, pricing, and deployment requirements.
- koiosmedical.com / products / koios-ds-breast
- koiosmedical.com / products
- www.accessdata.fda.gov / scripts / cdrh
- www.accessdata.fda.gov / cdrh_docs / pdf21
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