QLAB Advanced Quantification Software

K200974

Philips Healthcare · cleared 2020-06-03 · product code QIH · Radiology

FDA 510(k) summary for QLAB Advanced Quantification Software (K200974)

Constat organizes this clearance into predicate context, validation evidence, reported performance, postmarket signals, and reimbursement links. Each extracted claim stays tied to the public FDA source; missing fields remain explicitly unstated.

Validation studies
1
Cited predicates
2
Performance observations
0
Product code
QIH
Official FDA 510(k) database record ↗FDA 510(k) source PDF ↗

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 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)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

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

1
recalls in product code, 24mo
4
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
3
drift signals on this device
  • predicate_cohort_contagion

    K200974 shares predicate K150122 with K201632 (TOMTEC-ARENA), whose product code LLZ recorded 48 recall event(s) in the trailing 24 months.

    first seen 2026-07-15 · predicate:K150122 sibling:K201632

  • predicate_cohort_contagion

    K200974 shares predicate K191647 with K201012 (EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System), whose product code IYN recorded 85 recall event(s) in the trailing 24 months.

    first seen 2026-07-15 · predicate:K191647 sibling:K201012

  • recall_reason_pattern

    Software/algorithm-related recall in product code QIH (PIE Medical Imaging B.V., initiated 2026-05-07): "User measurement value reported by diagnostic bioimaging software intended to measure/visualize cardiovascular structures may be larger (0.8% to 34.4%) than the actual anatomical d" Recalling firm is another firm in the same product code.

    first seen 2026-08-26 · recall res_event_number:98930

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 2026-08-26.

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.

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Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K200974