Cardiovascular · 510(k) · 2016
FFRct
HEARTFLOW, INC.. Cleared by FDA on 24 August 2016 under submission K161772, product code PJA (coronary vascular physiologic simulation software). What FDA's record says, in FDA's words.
Device record · K161772
- Device. FFRctDEVICE
- Company. HEARTFLOW, INC.COMPANY
- Decision. 24 August 2016, 510(k), substantially equivalent (traditional review); received 28 June 2016DECISION
- Panel. CardiovascularPANEL
- Product code. PJA, Coronary Vascular Physiologic Simulation SoftwareCODE
- Regulation. 21 CFR 870.1415, Class IIREG
- Source. FDA database entry · decision document (7 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.
HeartFlow FFRCT is a coronary physiologic simulation software for the clinical quantitative and qualitative analysis of previously acquired Computed Tomography DICOM data for clinically stable symptomatic patients with coronary artery disease. It provides FFRCT, a mathematically derived quantity, computed from simulated pressure, velocity and blood flow information obtained from a 3D computer model generated from static coronary CT images. FFRCT analysis is intended to support the functional evaluation of coronary artery disease. The results of this analysis are provided to support qualified clinicians to aid in the evaluation and assessment of coronary arteries. The results of HeartFlow FFRCT are intended to be used by qualified clinicians in conjunction with the patient’s
The product code's definition, from FDA's classification record. A 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.
- Modalities namedCT
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 151 reports filed against devices carrying product code PJA. 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. The latest reports, in the reporter’s words:
22 September 2026 · Malfunction · Heartflow Analysis · Heartflow, Inc. · report 3021637148-2026-00019
Heartflow identified a potential Computed Tomography (CT) dataset was incorrectly accepted for processing an analysis.
18 September 2026 · Malfunction · Heartflow Analysis · Heartflow, Inc. · report 3021637148-2026-00017
Heartflow identified a potential false negative result.
18 September 2026 · Malfunction · Heartflow Analysis · Heartflow, Inc. · report 3021637148-2026-00016
Heartflow identified a Heartflow Analysis output was incorrectly released with FFRct values provided for the Right Coronary Artery (RCA) system.
18 September 2026 · Malfunction · Heartflow Analysis · Heartflow, Inc. · report 3021637148-2026-00015
Heartflow identified a Computed Tomography (CT) dataset was potentially incorrectly accepted for processing.
18 September 2026 · Malfunction · Heartflow Analysis · Heartflow, Inc. · report 3021637148-2026-00018
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 PJA, in Cardiovascular, from HEARTFLOW, INC., or cleared in 2016. 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.