VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)
K254001Spectrum Dynamics Medical, Ltd. · cleared 2026-01-13 · product code KPS · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“The subject device introduces a software-only modification to the cleared system by adding VERITAS.AI Noise Reduction, an optional deep-learning postprocessing feature integrated into the VERITON-CT Operator’s Console.”
source quote (p.5)
“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.”
source quote (p.7)
“Cybersecurity risk assessment and SBOM vulnerability analysis”
Validation studies (2)
Standalone
n=30 patients
endpoints: Signal Preservation: Lesion maximum voxel intensity (Bq/ml) was compared between NR-processed and nonprocessed images using linear regression.; Noise Suppression: Background SD/Mean ratio reduced by 28% (Bone) and 20% (Soft Tissue) after NR processing.
standards: IEC 62304, IEC 81001-5-1, AAMI TIR57, AAMI TIR97, ISO 14971, IEC 62366-1, NEMA NU-1:2023, IEC 60601-1, IEC 60601-1-2
Reader study (MRMC)
n=30 images
endpoints: noise; artifacts; overall IQ; diagnostic confidence; Inter-reader agreement
Reported performance (1 observation)
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
- 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). 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).