HeartFlow Analysis

K213857

HeartFlow, Inc. · cleared 2022-10-14 · product code PJA · Cardiovascular

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“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.”
AlgorithmAI-based medical device software; deep learning (AI and machine learning)
source quote (p.3)
“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. The core technology remains unchanged from the primary predicate and continues to be trained using deep learning (AI and machine learning) since 2015, to incorporate learnings from the volumes of CT data and studies.”
Adaptive (vs locked)No
source quote (p.5)
“All algorithms are then frozen and validated prior to product release.”
PCCPNo
Cybersecurity addressedNo

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
1
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

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/K213857