VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)

K254001

Spectrum Dynamics Medical, Ltd. · cleared 2026-01-13 · product code KPS · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.5)
“The VERITON CT 300/400 Digital SPECT/CT System is a hybrid imaging system combining SPECT and multi-slice CT imaging for anatomical and functional assessment. The subject device introduces a software-only modification to the cleared system by adding VERITAS.AI Noise Reduction, an optional deep-learning post-processing feature integrated into the VERITON-CT Operator's Console.”
Algorithmconvolutional neural network (CNN) for noise reduction
source quote (p.6)
“The AI module uses a convolutional neural network (CNN) to reduce noise in reconstructed SPECT images without altering acquisition parameters, hardware performance, radiation-emitting components, or quantitative reconstruction values.”
Adaptive (vs locked)No
source quote (p.6)
“The AI module: Operates only on reconstructed SPECT images Produces secondary enhanced images while preserving original images Does not alter quantitative values, raw data, or dosimetry Requires no changes to system hardware, acquisition workflow, or operator procedures”
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.7)
“Software Version 2.5.0 was developed under an IEC 62304 Class B SDLC and evaluated per FDA software and cybersecurity guidance, IEC 81001-5-1, AAMI TIR57, AAMI TIR97, ISO 14971, and IEC 62366-1. Cybersecurity risk assessment and SBOM vulnerability analysis”

Validation studies (3)

Bench

sample size not stated

endpoints: SNR; uniformity; resolution; detectability

Retrospective clinical

n=30 patients

endpoints: Lesion maximum voxel intensity (Bq/ml) comparison; Background SD/Mean ratio reduction

Reader study (MRMC)

n=30 images

endpoints: noise; artifacts; overall IQ; diagnostic confidence; inter-reader agreement

Reported performance (1 observation)

agreement_kappaas written: “Inter-reader agreement”stated without valueCI 92–100% across all domains
source quote (p.7)
“Inter-reader agreement: 92–100% across all domains.”

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

34
recalls in product code, 24mo
8
MAUDE reports in code, 12mo
-72%
vs code's own 3-yr baseline
4
drift signals on this device
  • recall_reason_pattern

    Software/algorithm-related recall in product code KPS (GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 9, Andrey Sakharov Haifa Israel, initiated 2025-12-24): "There is a potential intermittent issue on certain Omni Legend systems that can result in a streaking artifact in the PET clinical scan images. This streaking artifact is most eas" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98269

  • recall_reason_pattern

    Software/algorithm-related recall in product code KPS (GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel, initiated 2025-06-20): "Unintended radial detector motion may occur during patient setup or during patient scan if system does not have correct version of gantry software installed. Unintended detector mo" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:97193

  • recall_reason_pattern

    Software/algorithm-related recall in product code KPS (Hermes Medical Solutions AB Strandbergsgatan 16 Stockholm Sweden, initiated 2024-10-31): "Due a potential software/configuration issue that may result is incorrect alignment during reconstructing a SPECT/CT study." Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:95673

  • recall_reason_pattern

    Software/algorithm-related recall in product code KPS (Canon Medical System, USA, INC., initiated 2024-09-17): "When PET-CT system is executing reconstruction, if PET acquisition for another patient is performed (or PET reconstruction for another patient is performed from raw data processing" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:95471

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/K254001