QFR (3.0)

K243769

QFR Solutions bv · cleared 2025-04-04 · product code QHA · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“QFR is delivered as a standalone software package which is installed and running on a server system in the server room of the cathlab or the hospital.”
AlgorithmThe algorithm involves deep learning models for pre-classification of angiograms and coronary vessel segmentation, combined with analytical algorithms for 3D reconstruction and QFR analysis.
source quote (p.6)
“Angiograms are pre-classified by a deep learning model, identifying main epicardial vessels such as RCA, LAD, and LCx. ... First, the system runs another deep learning model for coronary vessel segmentation as input to identify anatomical corresponding points on both projections for automatic correction of the system distortions introduced by the isocenter offset and the respiration-induced heart motion.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedYes
source quote (p.10)
“Results have been summarized in the risk management report and cybersecurity assessment report.”

Validation studies (4)

Retrospective clinical

sample size not stated

endpoints: correct vessel classification

Retrospective clinical

sample size not stated

endpoints: correct start and end point detection

Retrospective clinical

sample size not stated

endpoints: correct detection of the ED frame

Bench

sample size not stated

endpoints: QFR measurement accuracy; automatic flow calculation performance

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); 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/K243769