Sonix Health

K230209

Ontact Health Co., Ltd. · cleared 2023-10-20 · product code QIH · Radiology

FDA 510(k) summary for Sonix Health (K230209)

Constat organizes this clearance into predicate context, validation evidence, reported performance, postmarket signals, and reimbursement links. Each extracted claim stays tied to the public FDA source; missing fields remain explicitly unstated.

Validation studies
1
Cited predicates
2
Performance observations
1
Product code
QIH
Official FDA 510(k) database record ↗FDA 510(k) source PDF ↗

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“Sonix Health will be offered as SW only, to be installed directly on customer PC hardware. Sonix Health is DICOM compliant and is used within a local network. Sonix Health utilizes a two-step algorithm. A single identification model identifies a view in the first step. The second step performs the deep learning algorithm according to the view. The deep learning algorithms for the second step are categorized as B-mode, M-mode, and Doppler algorithms. The main algorithm of Sonix Health is to identify the view and segment the anatomy in the image.”
AlgorithmTwo-step deep learning algorithm for view identification and segmentation. Deep learning algorithms for the second step are categorized as B-mode, M-mode, and Doppler algorithms.
source quote (p.5)
“Sonix Health utilizes a two-step algorithm. A single identification model identifies a view in the first step. The second step performs the deep learning algorithm according to the view. The deep learning algorithms for the second step are categorized as B-mode, M-mode, and Doppler algorithms. The main algorithm of Sonix Health is to identify the view and segment the anatomy in the image.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedYes
source quote (p.9)
“Throughout the verification and validation process, traceability was maintained, encompassing risk management (including Cyber Security and Usability).”

Validation studies (1)

Retrospective clinical

n=2,744 images · 2 site(s)

endpoints: accuracy for view recognition; correlation coefficient when compared to manual measurements by participating experts

standards: Digital Imaging and Communications in Medicine (DICOM) Set (Ps3.1 - .20), IEC 62304:2006, Medical Device Software - Software Life Cycle Processes., ISO 14971 Second edition 2007-03-01, Medical devices - Application of risk management to medical devices., IEC 62366-1 Edition 1.1 2020-06, Medical devices-Part 1 Application of usability engineering to medical devices.

Reported performance (1 observation)

accuracyas written: “average accuracy for view recognition”0.9822
source quote (p.9)
“Sonix Health passed the test in two categories: an average accuracy of 98.22% for view recognition”

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

1
recalls in product code, 24mo
4
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
4
drift signals on this device
  • predicate_cohort_contagion

    K230209 shares predicate K213544 with K240980 (EPIQ Series Diagnostic Ultrasound System), whose product code IYN recorded 85 recall event(s) in the trailing 24 months.

    first seen 2026-07-15 · predicate:K213544 sibling:K240980

  • predicate_cohort_contagion

    K230209 shares predicate K220975 with K223387 (V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System), whose product code IYN recorded 85 recall event(s) in the trailing 24 months.

    first seen 2026-07-15 · predicate:K220975 sibling:K223387

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K240645 (decision 2024-11-27) from Ontact Health Co., Ltd for a matching device line ("Sonix Health") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K240645

  • recall_reason_pattern

    Software/algorithm-related recall in product code QIH (PIE Medical Imaging B.V., initiated 2026-05-07): "User measurement value reported by diagnostic bioimaging software intended to measure/visualize cardiovascular structures may be larger (0.8% to 34.4%) than the actual anatomical d" Recalling firm is another firm in the same product code.

    first seen 2026-08-26 · recall res_event_number:98930

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 2026-08-26.

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.

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Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K230209