Cardiac Guidance
K243065Caption Health, Inc. · cleared 2025-01-15 · product code QJU · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“The Cardiac Guidance software is a radiological computer-assisted acquisition guidance system that provides real-time guidance during echocardiography to assist the user capture anatomically correct images representing standard 2D echocardiographic diagnostic views and orientations. This AI-powered, software-only device emulates the expertise of skilled sonographers.”
source quote (p.5)
“This AI-powered, software-only device emulates the expertise of skilled sonographers.”
source quote (p.1)
“FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP). Under section 515C(b)(1) of the Act, a new premarket notification is not required for a change to a device cleared under section 510(k) of the Act, if such change is consistent with an established PCCP granted pursuant to section 515C(b)(2) of the Act.”
Validation studies (7)
Retrospective clinical
sample size not stated
endpoints: predefined clinical endpoints
Bench
sample size not stated
endpoints: evaluate user interactions and ensure critical tasks remain unaffected by UI/UX modifications.
Bench
sample size not stated
endpoints: pre-defined acceptance criteria
Bench
sample size not stated
endpoints: pre-defined acceptance criteria
Bench
sample size not stated
endpoints: pre-defined acceptance criteria
Bench
sample size not stated
endpoints: pre-defined acceptance criteria
Bench
sample size not stated
endpoints: pre-defined acceptance criteria
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
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). 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).