Koios DS

K212616

Koios Medical, Inc. · cleared 2021-12-16 · product code POK · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“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.”
Algorithmartificial intelligence (AI)/machine learning (ML)-based computer-aided diagnosis (CADx) software device; two distinct AI/ML engines that use computer vision and machine learning techniques embedded within an engine capable of reading, interpreting, analyzing, and generating findings from ultrasound data, drawing upon knowledge learned from a large database of known cases, tying image features to their eventual diagnosis, to form a predictive model.
source quote (p.3)
“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 contains two distinct AI/ML engines to characterize breast lesions and thyroid nodules. Based on the structured data that exists within the DICOM header for a patient study, the Koios DS system calls the corresponding engine for analysis of the identified lesion or nodule. Each system uses computer vision and machine learning techniques embedded within an engine capable of reading, interpreting, analyzing, and generating findings from ultrasound data. The underlying breast and thyroid engines draw upon knowledge learned from a large database of known cases, tying image features to their eventual diagnosis, to form a predictive model.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (2)

Bench

n=900 images

endpoints: AUC; Sensitivity; Specificity

Reader study (MRMC)

n=650 cases · 2 site(s)

endpoints: area under the Receiver Operating Characteristic (ROC) Curve (AUC) when Koios DS and an ultrasound examination were combined (USE + DS), compared to unassisted TI-RADS based Reader performance (USE Alone); Sensitivity; Specificity

Reported performance (8 observations)

sensitivity0.97CI [0.96, 0.99]
source quote (p.15)
“System performance on the 900 cases reported an AUC of 92.9%, with a Sensitivity of 0.97 [0.96, 0.99] and a Specificity of 0.61 [0.57, 0.66].”
specificity0.61CI [0.57, 0.66]
source quote (p.15)
“System performance on the 900 cases reported an AUC of 92.9%, with a Sensitivity of 0.97 [0.96, 0.99] and a Specificity of 0.61 [0.57, 0.66].”
aurocas written: “auc”0.929
source quote (p.15)
“System performance on the 900 cases reported an AUC of 92.9%, with a Sensitivity of 0.97 [0.96, 0.99] and a Specificity of 0.61 [0.57, 0.66].”
aurocas written: “Thyroid Engine AUC”0.798
source quote (p.16)
“When applied to diagnoses made using ACR TI-RADS guidelines, the AI Adapter and descriptor predictors achieved an AUC of 79.8%, demonstrating a significant increase over the average physician AUC.”
sensitivityas written: “Thyroid Engine Sensitivity (recommending biopsy)”0.644CI [0.545, 0.744]
source quote (p.16)
“When recommending biopsy, the system's sensitivity is 0.644 [0.545, 0.744] and specificity is 0.612 [0.566, 0.658].”
specificityas written: “Thyroid Engine Specificity (recommending biopsy)”0.612CI [0.566, 0.658]
source quote (p.16)
“When recommending biopsy, the system's sensitivity is 0.644 [0.545, 0.744] and specificity is 0.612 [0.566, 0.658].”
aurocas written: “Thyroid Clinical Study AUC Improvement (US readers, parametric)”0.074CI [0.051, 0.098]
source quote (p.31)
“Primary endpoints were successfully met, demonstrating a statistically significant improvement of 0.074 [0.051, 0.098] (95% confidence interval) in overall reader performance of US-based readers when utilizing Koios DS for the interpretation of US-based thyroid ultrasound studies.”
aurocas written: “Breast Engine AUC (additional 50 cases)”0.93CI [0.914, 0.946 95% CI]
source quote (p.15)
“An additional 50 new cases were added to the set and evaluated to test the subject device for robustness to dataset drift. This additional test generated a resulting AUC of 0.930 [0.914, 0.946 95% CI], demonstrating there is no degradation in performance attributable to dataset drift.”

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
1
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K242130 (decision 2024-11-15) from Koios Medical, Inc. for a matching device line ("Koios DS") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K242130

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K212616