Cardiovascular · 510(k) · 2022
HeartFlow Analysis
HeartFlow, Inc.. Cleared by FDA on 14 October 2022 under submission K213857, product code PJA (coronary vascular physiologic simulation software). What FDA's record says, in FDA's words.
Device record · K213857
- Device. HeartFlow AnalysisDEVICE
- Company. HeartFlow, Inc.COMPANY
- Decision. 14 October 2022, 510(k), substantially equivalent (traditional review); received 10 December 2021DECISION
- Panel. CardiovascularPANEL
- Product code. PJA, Coronary Vascular Physiologic Simulation SoftwareCODE
- Regulation. 21 CFR 870.1415, Class IIREG
- Source. FDA database entry · decision document (8 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.
The HeartFlow Analysis is an AI-based medical device software for the clinical quantitative and qualitative analysis of previously acquired Computed Tomography DICOM data for patients with suspected coronary artery disease. It provides anatomic data, plaque identification and characterization, as well as the calculations of FFRCT, a coronary physiological simulation, computed from simulated pressure, velocity and blood flow information obtained from a 3D computer model generated from static coronary CT images. The HeartFlow Analysis is intended to support the risk assessment and functional evaluation of coronary artery disease. The HeartFlow Analysis is provided to support qualified clinicians to aid in the evaluation and risk assessment of coronary artery disease. The HeartFlow Analysis is 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 judgment. 6 Technological Characteristics of Device The HeartFlow Analysis is a software medical device that allows for the quantitative and qualitative analysis of Coronary Computed Tomography Angiography (cCTA). The predicates and this product have the same
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
- Mentionsdetection or identification of findings
- Mentionsa diagnostic claim
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 2022. 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.