QLAB Advanced Quantification Software

K191647

Philips Healthcare · cleared 2019-12-20 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“QLAB Advanced Quantification Software is a software application package. It is designed to view and quantify image data acquired on Philips ultrasound systems.”
Algorithmmachine learning algorithms
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.”
Adaptive (vs locked)No
PCCPNo
Cybersecurity addressedNo

Validation studies (2)

Standalone

sample size not stated

endpoints: RV end diastolic volume error rates below 15%; end diastolic RV volumes with 8.3 ml RMSE; end systolic RV volumes with 2.7 ml RMSE; RV ejection fraction with 2.7% RMSE

Retrospective clinical

sample size not stated

endpoints: accurate and highly reproducible quantification; less than 15% difference from the 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

0
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
1
drift signals on this device
  • 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); 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/K191647