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

Spectrum Dynamics Medical, Ltd. · K254001 · 2026-01-13

VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464) is an AI-enabled medical device from Spectrum Dynamics Medical, Ltd., listed by FDA (510(k), K254001) with a decision date of 2026-01-13. Review panel: Radiology.

FDA submission numberK254001
Pathway510(k)
CompanySpectrum Dynamics Medical, Ltd.
Review panel (specialty)Radiology
FDA decision date2026-01-13
DecisionSubstantially Equivalent
Product codeKPS
ClassificationSystem, Tomography, Computed, Emission
Device class2
Regulation number892.1200
Review time (calendar days)29
Applicant countryIL

Official FDA database record · FDA AI-enabled device list

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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.