Cardiovascular · 510(k) · 2018
FFRangio System
CathWorks Ltd. Cleared by FDA on 19 December 2018 under submission K182149, product code QEK (angiographic coronary vascular physiologic simulation software). What FDA's record says, in FDA's words.
Device record · K182149
- Device. FFRangio SystemDEVICE
- Company. CathWorks Ltd (IL)COMPANY
- Decision. 19 December 2018, 510(k), substantially equivalent (traditional review); received 8 August 2018DECISION
- Panel. CardiovascularPANEL
- Product code. QEK, Angiographic Coronary Vascular Physiologic Simulation SoftwareCODE
- Regulation. 21 CFR 870.1415, Class IIREG
- Source. FDA database entry · decision document (11 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
CathWorks FFRangio is a software device for the clinical quantitative and qualitative analysis of previously acquired angiography DICOM data for patients with coronary artery disease. It provides FFRangio, a mathematically derived quantity, computed from simulated blood flow information obtained from a 3D computer model, generated from coronary angiography images. FFRangio analysis is intended to support the functional evaluation of coronary artery disease. The results of this analysis are provided as a supportive aid for qualified clinicians in the evaluation and assessment of coronary arteries physiology. The results of CathWorks FFRangio are intended to be used by qualified clinicians in conjunction with the patient’s clinical history, symptoms, and other diagnostic tests, as well as the clinician’s professional evaluation.
The product code's definition, from FDA's classification record. An angiographic coronary vascular physiologic simulation software device is intended to aid in the identification of functionally significant cardiovascular disease.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsa diagnostic claim
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QEK. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code QEK, in Cardiovascular, from CathWorks Ltd, or cleared in 2018. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.