Caption Guidance

K201992

Caption Health · cleared 2020-09-18 · product code QJU · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“Caption Guidance is a software-only device that uses artificial intelligence to emulate the expertise of sonographers.”
Algorithmartificial intelligence
source quote (p.4)
“Caption Guidance is a software-only device that uses artificial intelligence to emulate the expertise of sonographers.”
Adaptive (vs locked)No
source quote (p.5)
“The PCCP does not include provisions for implementation of adaptive algorithms that will continuously learn in the field.”
PCCPYes
source quote (p.5)
“The purpose of the 510(k) submission is to address the modification of a predetermined change control plan (PCCP) to outline anticipated modifications to the Caption Guidance software and the methods that will be utilized to implement those modifications in a controlled manner while maintaining safety and efficacy.”
Cybersecurity addressedFDA source did not state this

Validation studies (0)

FDA source did not describe a validation study.

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

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
0
drift signals on this device

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/K201992