QLAB Advanced Quantification Software
K191647Philips Healthcare · cleared 2019-12-20 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.3)
“QLAB Advanced Quantification Software is a software application package.”
source quote (p.5)
“The proposed 3D Auto RV application is based on the automatic segmentation technology of HeartModel applied to the Right Ventricle, and uses machine learning algorithms to identify the endocardial contours of the Right Ventricle.”
Validation studies (2)
Retrospective clinical
sample size not stated
endpoints: RV end diastolic volume error rates; root mean square error (RMSE) for end diastolic RV volumes; root mean square error (RMSE) for end systolic RV volumes; root mean square error (RMSE) for RV ejection fraction
Retrospective clinical
sample size not stated
endpoints: accuracy and reproducibility of quantification; difference from CMR measurements of RV volume
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) K200974 (decision 2020-06-03) from Philips Healthcare for a matching device line ("QLAB Advanced Quantification Software") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K200974
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).