Caption Guidance
K200755Caption Health · cleared 2020-04-16 · product code QJU · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“Caption Guidance is a software-only device that uses artificial intelligence to emulate the expertise of sonographers.”
source quote (p.4)
“Caption Guidance is a software-only device that uses artificial intelligence to emulate the expertise of sonographers.”
source quote (p.6)
“11. Cybersecurity”
Validation studies (2)
Standalone
sample size not stated
endpoints: Frame-level PG prediction of the probe maneuver needed to acquire an image/frame of heart, for a specific view.; Clip-level PG prediction of the probe maneuver needed to acquire a diagnostic quality clip for a specific view.
Reader study (MRMC)
n=16 other
endpoints: assesses the critical tasks potentially impacted by the modification to the prescriptive guidance features; no use errors associated with critical tasks likely to lead to patient injury
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
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K201992 (decision 2020-09-18) from Caption Health for a matching device line ("Caption Guidance") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K201992
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).