Cardiovascular · 510(k) · 2018
FFRct
HeartFlow, Inc. Cleared by FDA on 6 December 2018 under submission K182035, product code PJA (coronary vascular physiologic simulation software). What FDA's record says, in FDA's words.
Device record · K182035
- Device. FFRctDEVICE
- Company. HeartFlow, IncCOMPANY
- Decision. 6 December 2018, 510(k), substantially equivalent (special review); received 30 July 2018DECISION
- Panel. CardiovascularPANEL
- Product code. PJA, Coronary Vascular Physiologic Simulation SoftwareCODE
- Regulation. 21 CFR 870.1415, Class IIREG
- Source. FDA database entry · decision document (5 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 could not be read from a public decision document for this submission on the retrieval date (the document is absent, scanned without text, or filed under another number). FDA's database entry is the place to read it.
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.
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 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.