Device
QFR is software intended to be used for performing calculations in X-ray angiographic images of the coronary arteries. QFR enables interventional cardiologists and researchers to o...
Manufacturer
QFR Solutions B.V.
QFR Solutions B.V.
Model: 3.1
DI: G725QFR310
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-11
Current Version: 2026-05-19
Distribution End: 2031-05-11
Description
QFR is software intended to be used for performing calculations in X-ray angiographic images of the coronary arteries. QFR enables interventional cardiologists and researchers to obtain quantifications of one or more lesions in the analyzed coronary vessel segment. In particular, QFR provides:
• Quantitative results of coronary vessel segments based on a 3D reconstructed model;
• Dimensions of the cardiovascular vessels and lesions;
• Quantification of the pressure drop in coronary vessels
QFR is indicated for use in clinical settings where validated and reproducible quantified results are needed to support the assessment of coronary vessels in X-ray angiographic images, for use on individual patients with coronary artery disease.
When the quantified results provided by QFR are used in a clinical setting on X-ray images of an individual patient, the results are only intended for use by the responsible clinicians.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
736c7b6a-1ded-4e0a-9923-a9e6794321d0
Distribution Status:
In Commercial Distribution
DUNS Number:
492175795
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
G725QFR310
Item #1 - Device ID Type:
Primary
Item #1 - Device ID Issuing Agency:
HIBCC
Item #2 - Device ID:
G725QFR300
Item #2 - Device ID Type:
Previous
Item #2 - Device ID Issuing Agency:
HIBCC
GMDN
Code: 43472
Name: Laboratory instrument/analyser application software IVD
Definition:
An in vitro diagnostic software program intended to be used with an instrument/analyser (e.g., microscope slide digital imaging scanner, immunoassay analyser, real-time PCR machine), or a data management device connected to the instrument/analyser, to: 1) facilitate user-controlled device function [e.g., incubation control]; 2) assist data processing, display, or communication [e.g., image conversion]; and/or 3) produce raw-data-derived qualitative result calculations based on specified criteria [positive or negative assay result]. This software does not use demographic or clinical data to produce a patient score (i.e., it is not interpretive).
FDA Product Codes
LLZ
System, Image Processing, Radiological
Premarket Submissions
Submission Number:
K243769
Supplement Number:
000