X1-FFR
K251355Spectrawave, Inc. · cleared 2025-10-17 · product code QHA · Radiology
Premarket evidence — what FDA accepted
Device typesamd
source quote (p.5)
“The SpectraWAVE X1-FFR Software is a standalone medical device which is used in the catheterization lab as an angiography image assessment tool for assessing Fractional Flow Reserve using non-invasive quantitative and functional analysis of coronary vasculature.”
AlgorithmAI-derived algorithms for vessel segmentation and contouring; Analytical (non-AI) models for generating FFR values.
source quote (p.6)
“AI-derived algorithms are deployed on the device to support vessel segmentation and contouring. Analytical (non-Al) models are used for generating FFR values.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.11)
“SpectraWAVE X1-FFR Software's cybersecurity and interoperability risks have been appropriately mitigated to provide reasonable assurance of the safety and effectiveness of the device.”
Validation studies (1)
Retrospective clinical
n=285 patients
standards: IEC 62304
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
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). 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).