QFR (3.0) uses paired coronary X-ray angiographic DICOM acquisitions to calculate three-dimensional vessel and lesion measurements and pressure-drop quantification for interventional cardiologist or researcher review in patients with coronary artery disease.
Evidence status: each field shows source quality, applicability, and review date. Research pending, information not established in reviewed sources, and vendor documentation pending are distinct outcomes.
Clinical fit
What this tool is for
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Exact purpose
QFR (3.0) uses paired coronary X-ray angiographic DICOM acquisitions to calculate three-dimensional vessel and lesion measurements and pressure-drop quantification for interventional cardiologist or researcher review in patients with coronary artery disease.
FDA source Exact FDA submission Checked 2026-09-07
Interventional cardiologists or researchers who review coronary angiography; responsible clinicians must review and may correct analysis inputs and contours.
FDA source Exact FDA submission Checked 2026-09-07
Post-processing decision support for quantitative coronary vessel and lesion assessment and pressure-drop estimation; it supplements, rather than replaces, angiographic and clinical judgment.
FDA source Exact FDA submission Checked 2026-09-07
Coronary X-ray angiography DICOM acquisitions from a monoplane or biplane system, with two suitable projections separated by at least 25 degrees and adequate calibration and image quality.
FDA source Exact FDA submission Checked 2026-09-07
The analysis requires suitable paired angiographic views, calibration, at least five frames, and adequate vessel visibility. The user must review and correct contours or reference diameter when needed; incorrect contours or reference diameter can produce an incorrect QFR result. The output is not a replacement for clinical judgment.
FDA source Exact FDA submission Checked 2026-09-07
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
FDA submission
K243769
FDA source Exact FDA submission Checked 2026-08-31
Use these fields to structure a vendor demo, security review, and implementation estimate.
Integration
The exact software imports coronary XA DICOM studies and can exchange studies and reports with PACS through DICOM services; local modality, PACS, worklist, export, and report routing require acceptance testing.
FDA source Exact FDA submission Checked 2026-09-07
The exact FDA packet and QFR manual describe a server installed in the organization network or cathlab/hospital server room, accessed through a web browser; the manual states the QFR server is not cloud or internet hosted for the reviewed version.
FDA source Exact FDA submission Checked 2026-09-07
Reviewed sources checked Exact FDA submission Checked 2026-09-07
The reviewed packet and manual describe local deployment, user roles, and audit-trail functions but do not establish a current scoped security attestation, encryption configuration, retention, vulnerability management, or incident response for the installed K243769 release.
Training and support
Use requires trained interventional cardiologist or researcher review of projection selection, calibration, vessel and lesion contours, reference diameter, QFR result, and report; local competency and escalation procedures remain site responsibilities.
FDA source Exact FDA submission Checked 2026-09-07
The QFR manual places the QFR server in the organization network and states it is not cloud or internet hosted for the reviewed version; access is through a web browser and local DICOM connections must be configured.
product family · checked 2026-09-07
Manual version 3.0.36.6 was reviewed; confirm that the installed K243769 release has the same deployment behavior.
The manual documents DICOM connection administration, PACS export, audit trail, user roles, and report archiving when configured; test modality import, projection selection, export, report delivery, and failure recovery locally.
The reviewed manual requires XA studies with grayscale square pixels, fixed angulation, calibration, at least five frames, and two projections with at least 25 degrees between angles; invalid or incomplete acquisitions may block or distort analysis.
Retrospective regulatory validation of vessel classification, endpoint detection, and QFR image-analysis outputs on coronary X-ray angiography. · Coronary angiography studies representative of intended interventional cardiology or research use; the reviewed FDA summary reports endpoint percentages without a single overall sample count.
exact submission · Tested version: QFR 3.0 configuration described in K243769 · Sponsor or vendor study
K243769
Manufacturer-submitted FDA evidence; it is not an independent clinical-outcome study.
These are common procurement questions; unknown values remain visible until a source supports them.
Pricing and total cost
Not established in reviewed sources
Reviewed sources checked Exact FDA submission Checked 2026-09-07
No public list price or contract unit for the exact K243769 configuration was established in the reviewed official sources.
Reimbursement and coding
Research pending
Needs research Exact FDA submission Checked 2026-09-07
CMS plaque-policy review was not applied to this angiography dossier; no product-specific coverage determination is made.
Safety and lifecycle
Postmarket record
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
Postmarket safety review
The wave22 exact-submission recall query returned no native recall record for K243769. This does not establish absence of family, later-version, or adverse-event information.
Public source Exact FDA submission Checked 2026-09-07
Verify security and privacy controls: The reviewed packet and manual describe local deployment, user roles, and audit-trail functions but do not establish a current scoped security attestation, encryption configuration, retention, vulnerability management, or incident response for the installed K243769 release.
Verify pricing and total cost: No public list price or contract unit for the exact K243769 configuration was established in the reviewed official sources.
Verify reimbursement and coding relevance: CMS plaque-policy review was not applied to this angiography dossier; no product-specific coverage determination is made.
This audit distinguishes completed source review from fields that have not yet been researched.
Human reviewedStatus
2026-09-07Last searched
24Fields reviewed
11Source classes checked
0Reviewed PubMed leads
0Reviewed trial leads
0Unreviewed FDA recall leads
The stored PubMed and ClinicalTrials.gov candidate arrays were screened and were empty. No paper or trial was promoted; empty stored arrays do not establish that no external literature or trials exist. The current discovery snapshot contains 0 PubMed and 0 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.
Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.
Source classes: fda ai list, fda decision summary, acr ai central product, vendor documentation, fda device recall, literature index, trial registry, stored candidate metadata, pubmed, clinical trials, openfda device recall
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