Caption Guidance
K201992Caption 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. In accordance with the PCCP, all algorithm modifications will be trained, tuned, and locked prior to release of the software to the field. The PCCP does not include provisions for implementation of adaptive algorithms that will continuously learn in the field.”
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). 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).