HeartFlow Analysis

K203329

HeartFlow, Inc. · cleared 2021-01-08 · product code PJA · Cardiovascular

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“The HeartFlow Analysis is a coronary physiological simulation software developed for the clinical quantitative and qualitative analysis of CT DICOM data.”
AlgorithmCoronary physiological simulation software that computes FFRCT, a mathematically derived quantity, from simulated pressure, velocity, and blood flow information obtained from a 3D computer model generated from static coronary CT images.
source quote (p.3)
“The HeartFlow Analysis is a coronary physiological 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 the calculations of 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.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (2)

Bench

sample size not stated

Retrospective clinical

sample size not stated

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

0
recalls in product code, 24mo
14
MAUDE reports in code, 12mo
+35%
vs code's own 3-yr baseline
2
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K250902 (decision 2025-07-18) from HeartFlow, Inc. for a matching device line ("HeartFlow Analysis") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K250902

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K213857 (decision 2022-10-14) from HeartFlow, Inc. for a matching device line ("HeartFlow Analysis") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K213857

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Cardiovascular panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K203329