Caption Guidance

DEN190040

Bay Labs, Inc. · granted 2020-02-07 · product code QJU · Radiology

FDA De Novo summary for Caption Guidance (DEN190040)

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
4
Cited predicates
2
Performance observations
1
Product code
QJU
FDA De Novo source PDF ↗

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.2)
“Caption Guidance is a software-only device that uses artificial intelligence to emulate the expertise of sonographers.”
Algorithmdeep learning image analysis algorithms
source quote (p.9)
“The Caption Guidance device is powered by deep learning image analysis algorithms that assist medical professionals in the acquisition of echocardiograms.”
Adaptive (vs locked)Yes
source quote (p.9)
“Caption Health will make future algorithm improvements under a Predetermined Change Control Plan (PCCP).”
PCCPYes
source quote (p.9)
“Caption Health will make future algorithm improvements under a Predetermined Change Control Plan (PCCP).”
Cybersecurity addressedYes
source quote (p.3)
“The software documentation included: ... 11. Cybersecurity”

Validation studies (4)

Bench

sample size not stated

endpoints: Frame-level prediction of the current pose of the probe; Relative image quality predication of the current pose of the probe; Auto-Capture of clinically-acceptable images and clips; Frame-level PG prediction of the probe maneuver needed to acquire an image/frame of heart; Clip-level PG prediction of the probe maneuver needed to acquire a diagnostic-quality clip

standards: FDA guidance document “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.”, Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment (UD3-2004)

Retrospective clinical

n=50 patients

endpoints: diagnostic quality images in a high proportion of clips; comparable image quality; high specificity of the auto-capture feature (97.85% of auto-captured clips were diagnostic)

Prospective clinical

n=240 patients

endpoints: Qualitative Visual Assessment of Left Ventricular Size; Qualitative Visual Assessment of Global Left Ventricular Function; Qualitative Visual Assessment of Right Ventricular Size; Qualitative Visual Assessment of Non-Trivial Pericardial Effusion; Qualitative visual assessment of inferior vena cava size; Qualitative visual assessment of right ventricular function; Qualitative visual assessment of left atrial size; Qualitative visual assessment of aortic valve; Qualitative visual assessment of mitral valve; Qualitative visual assessment of tricuspid valve

Standalone

sample size not stated · 1 site(s)

endpoints: 100% of critical tasks passed across all user types; No use errors were found that could cause harm; average of 76% of views were auto-captured per user across all 5 user groups

Reported performance (1 observation)

specificity0.9785
source quote (p.5)
“Importantly, the high specificity of the auto-capture feature (97.85% of auto-captured clips were diagnostic) demonstrated that a registered sonographer can rely on the auto-capture feature when using Caption Guidance.”

Each value carries its own analysis unit and task — never compare or pool across devices. Source: De Novo decision 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
4
drift signals on this device
  • predicate_cohort_contagion

    DEN190040 shares predicate K173780 with K191171 (EchoGo Core), whose product code QIH recorded 1 recall event(s) in the trailing 24 months.

    first seen 2026-09-02 · predicate:K173780 sibling:K191171

  • predicate_cohort_contagion

    DEN190040 shares predicate K173780 with K200621 (Caption Interpretation Automated Ejection Fraction Software), whose product code QIH recorded 1 recall event(s) in the trailing 24 months.

    first seen 2026-09-02 · predicate:K173780 sibling:K200621

  • predicate_cohort_contagion

    DEN190040 shares predicate K173780 with K210791 (Us2.v1), whose product code QIH recorded 1 recall event(s) in the trailing 24 months.

    first seen 2026-09-02 · predicate:K173780 sibling:K210791

  • predicate_cohort_contagion

    DEN190040 shares predicate K173780 with K220956 (Libby Echo:Prio), whose product code QIH recorded 1 recall event(s) in the trailing 24 months.

    first seen 2026-09-02 · predicate:K173780 sibling:K220956

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 2026-09-02.

Reimbursement — how devices like this got paid

ntap2021-10-01

NTAP max add-on $1,868.1 (expired) ·

NTAP granted FY2022 for AI-guided cardiac ultrasound image acquisition. Billed under ICD-10-PCS X2JAX47 (new technology group 7). Facility payment only; does not alter the physician professional fee. Discontinued after FY2023.

FDA De Novo DEN190040 decision summaryFY2022 NTAP list (HIA coding review)

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to De Novo 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.

Related FDA clearances

More AI/ML devices under product code QJU

These are recent clearances in the same FDA product-code category. Shared classification does not by itself make a device an appropriate predicate.

UltraSight Guidance

K251416

Ultrasight , Ltd.

cleared 2025-12-17

HeartFocus (V.1.1.1)

K242807

Deski

cleared 2025-04-04

Cardiac Guidance

K243065

Caption Health, Inc.

cleared 2025-01-15

UltraSight AI Guidance

K223347

UltraSight Inc.

cleared 2023-07-24

Caption Guidance

K201992

Caption Health

cleared 2020-09-18

Caption Guidance

K200755

Caption Health

cleared 2020-04-16

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/DEN190040