FFRct

K152733

HEARTFLOW, INC. · cleared 2016-01-13 · product code PJA · Cardiovascular

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“The HeartFlow FFRCT device is a software medical device that allows for the quantitative and qualitative analysis of Coronary Computed Tomography Angiography (CCTA).”
Algorithmmathematically derived quantity, computed from simulated pressure, velocity and blood flow information obtained from a 3D computer model generated from static coronary CT images; computational methods
source quote (p.3)
“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.”
Adaptive (vs locked)No
PCCPNo
Cybersecurity addressedNo

Validation studies (2)

Bench

sample size not stated

Prospective clinical

n=254 patients · 11 site(s)

endpoints: per-vessel sensitivity to detect hemodynamically significant obstruction; per-vessel specificity to detect hemodynamically significant obstruction

Reported performance (7 observations)

sensitivity84.2CI 75.8%
source quote (p.10)
“The per-vessel sensitivity of FFRCT in the ITD population was 84.2% with a lower one-sided 95% CI of 75.8%.”
specificity84.9CI 80.4%
source quote (p.10)
“The per-vessel specificity of FFRCT in the ITD population was 84.9%. The lower one-sided 95% CI was 80.4% and was above the protocol specified target goal of 55%, therefore the second null hypothesis was rejected and FFRCT was considered to have met the specificity target goal.”
accuracyas written: “Per-Subject Diagnostic Accuracy”80CI 74.4%-84.6%
source quote (p.11)
“Diagnostic Accuracy 80.0% (74.4%-84.6%)”
sensitivityas written: “Per-Subject Sensitivity”87.8CI 78.5%-93.5%
source quote (p.11)
“Sensitivity 87.8% (78.5%-93.5%)”
specificityas written: “Per-Subject Specificity”76.4CI 69.3%-82.3%
source quote (p.11)
“Specificity 76.4% (69.3%-82.3%)”
ppvas written: “Per-Subject PPV”63.1CI 53.5%-71.8%
source quote (p.11)
“PPV 63.1% (53.5%-71.8%)”
npvas written: “Per-Subject NPV”93.2CI 87.5%-96.4%
source quote (p.11)
“NPV 93.2% (87.5%-96.4%)”

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
3
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K190925 (decision 2019-08-15) from HeartFlow, Inc. for a matching device line ("HeartFlow FFRct Analysis") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K190925

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K182035 (decision 2018-12-06) from HeartFlow, Inc for a matching device line ("FFRct") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K182035

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K161772 (decision 2016-08-24) from HEARTFLOW, INC. for a matching device line ("FFRct") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K161772

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/K152733