TruSPECT Processing Station

K253532

Spectrum Dynamics Medical, Ltd. · cleared 2025-12-30 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.6)

“The TruSPECT Processing Station is a software-only medical device (SaMD) designed to operate on a dedicated, high-performance computer platform.”

AlgorithmNon-adaptive machine learning algorithms trained with clinical data

source quote (p.8)

“Non-adaptive machine learning algorithms trained with clinical data”

Adaptive (vs locked)No

source quote (p.8)

“Non-adaptive machine learning algorithms trained with clinical data”

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (2)

Retrospective clinical

n=352 patients · 3 site(s)

endpoints: LVEF; EDV; Perfusion Volume; TPD

standards: NEMA PS3.1–3.20, IEC 62304, ISO 13485

Reader study (MRMC)

n=24 patients

endpoints: visual similarity; inter-observer percent agreement

Reported performance (1 observation)

agreement_kappaas written: “Inter-observer percent agreement”stated without value

source quote (p.9)

“inter-observer percent agreement after dichotomization (scores ≥3 vs <3) was 97–100% across key metrics.”

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

recalls in product code, 24mo

MAUDE reports in code, 12mo

—

vs code's own 3-yr baseline

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).