TruSPECT Processing Station

K253532

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

FDA 510(k) summary for TruSPECT Processing Station (K253532)

Constat organizes this clearance into predicate context, validation evidence, reported performance, postmarket signals, and reimbursement links. Each extracted claim stays tied to the public FDA source; missing fields remain explicitly unstated.

Validation studies
2
Cited predicates
1
Performance observations
1
Product code
QIH
Official FDA 510(k) database record ↗FDA 510(k) source PDF ↗

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

1
recalls in product code, 24mo
4
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
1
drift signals on this device
  • recall_reason_pattern

    Software/algorithm-related recall in product code QIH (PIE Medical Imaging B.V., initiated 2026-05-07): "User measurement value reported by diagnostic bioimaging software intended to measure/visualize cardiovascular structures may be larger (0.8% to 34.4%) than the actual anatomical d" Recalling firm is another firm in the same product code.

    first seen 2026-08-26 · recall res_event_number:98930

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 2026-08-26.

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.

Related FDA clearances

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Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K253532