Cleared Special

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. · Radiology
Jan 2026
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K254001 is an FDA 510(k) clearance for the VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464), a System, Tomography, Computed, Emission (Class II — Special Controls, product code KPS), submitted by Spectrum Dynamics Medical, Ltd. (Caesarea, IL). The FDA issued a Cleared decision on January 13, 2026, 29 days after receiving the submission on December 15, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1200.

Submission Details

510(k) Number K254001 FDA.gov
FDA Decision Cleared SESE
Date Received December 15, 2025
Decision Date January 13, 2026
Days to Decision 29 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code KPS — System, Tomography, Computed, Emission
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1200

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