FFRangio System

K182149

CathWorks Ltd · cleared 2018-12-19 · product code QEK · Cardiovascular

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“CathWorks FFRangio™ is a software device for the clinical quantitative and qualitative analysis of previously acquired angiography DICOM data for patients with coronary artery disease.”
Algorithmmathematically derived quantity, computed from simulated blood flow information obtained from a 3D computer model, generated from coronary angiography images
source quote (p.3)
“It provides FFRangio™, a mathematically derived quantity, computed from simulated blood flow information obtained from a 3D computer model, generated from coronary angiography images.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.7)
“Software documentation consistent with FDA's guidance “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices,” May 11, 2005, for moderate level of concern software including a comprehensive risk analysis, software verification and validation, off-the-shelf software integrity, and cybersecurity considerations.”

Validation studies (4)

Bench

sample size not stated

Retrospective clinical

n=203 cases · 4 site(s)

endpoints: sensitivity; specificity; diagnostic accuracy

Prospective clinical

n=382 patients · 10 site(s)

endpoints: sensitivity; specificity; accuracy; correlation with invasive FFR

Reader study (MRMC)

n=19 other

standards: ANSI/AAMI/IEC 62366-1:2015

Reported performance (2 observations)

sensitivity93.5CI 87.8% - 96.6%
source quote (p.9)
“The per vessel sensitivity of FFRangio™ was 93.5% with a lower one-sided 95% CI of 87.8%. The per-vessel specificity of FFRangio™ was 91.2% with a lower one-sided 95% CI of 86.0%. Both of the lower one-sided confidence limits for sensitivity and specificity were significantly above the pre-specified target goals of 70% and 75%, respectively, and were considered acceptable. The results are shown in the table below.”
specificity91.2CI 86.0% - 94.6%
source quote (p.9)
“The per vessel sensitivity of FFRangio™ was 93.5% with a lower one-sided 95% CI of 87.8%. The per-vessel specificity of FFRangio™ was 91.2% with a lower one-sided 95% CI of 86.0%. Both of the lower one-sided confidence limits for sensitivity and specificity were significantly above the pre-specified target goals of 70% and 75%, respectively, and were considered acceptable. The results are shown in the table below.”

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
0
MAUDE reports in code, 12mo
—
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) K192442 (decision 2019-12-09) from CathWorks Ltd for a matching device line ("FFRangio") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K192442

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/K182149