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.”
Algorithmartificial intelligence-based post-processing module for denoising low-count D-SPECT myocardial perfusion SPECT images, incorporating pre-trained neural networks within the iterative reconstruction process and traditional image processing algorithms.
source quote (p.5)
“The current submission introduces the TruClear AI module, a post-processing artificial intelligence algorithm designed to reduce noise in low-count D-SPECT Tc-99m myocardial perfusion imaging (MPI) studies. TruSPECT enhances existing applications to improve workflow efficiency by incorporating both pre-trained neural networks within the iterative reconstruction process and traditional image processing algorithms.”
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)

Bench

sample size not stated

standards: NEMA PS3.1–3.20, IEC 62304, 21 CFR 820, ISO 13485

Retrospective clinical

n=352 patients · 3 site(s)

endpoints: TPD; volume; EDV; LVEF; inter-observer percent agreement

Reported performance (1 observation)

agreement_kappaas written: “Inter-observer percent agreement”stated without valueCI 97–100%
source quote (p.9)
“Two independent, board-certified nuclear medicine physicians visually compared denoised low-count images to the high-count reference using a 5-point Likert scale; 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

0
recalls in product code, 24mo
3
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); 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 Radiology 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/K253532