QLAB Advanced Quantification Software
K200974Philips Healthcare · cleared 2020-06-03 · product code QIH · Radiology
Premarket evidence — what FDA accepted
Device typesamd
source quote (p.7)
“The System Components of the subject QLAB System and predicate devices identified are identical as all devices are software only”
Algorithmmachine-learning derived segmentation engine
source quote (p.8)
“The 3D Auto MV Q-App is a semi-automatic tool that essentially is an integration of the machine-learning derived segmentation engine of the QLAB HeartModel and the TOMTEC-Arena TTA2 4D MV-Assessment application thereby providing a dynamic Mitral Valve clinical quantification tool.”
Adaptive (vs locked)No
source quote (p.8)
“Algorithm Training procedures is the same between the subject 3D Auto MV and the predicate HeartModel, with the exception being that the algorithm is being applied to the LV in Heartmodel, while in 3D Auto MV the algorithm is applied to the MV.”
PCCPNo
Cybersecurity addressedNo
Validation studies (1)
Bench
sample size not stated
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
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).