510(k) · Radiology

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

by Spectrum Dynamics Medical, Ltd.

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. that the U.S. FDA cleared through 510(k) K254001 on January 13, 2026. Its lead review panel is Radiology and its primary product code is KPS (System, Tomography, Computed, Emission).

See also FDA-cleared AI radiology devices in 2026, all FDA AI clearances in 2026, top radiology AI devices.

Key facts

Submission numberK254001
Pathway510(k)
Date of final decision
Company (FDA list)Spectrum Dynamics Medical, Ltd.
Lead review panelRadiology
Primary product codeKPS — System, Tomography, Computed, Emission
Applicant (openFDA)Spectrum Dynamics Medical, Ltd.
Applicant locationCaesarea, IL
Device classClass 2
Regulation number21 CFR 892.1200
Decision codeSESE
Submission typeSpecial

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464) went through this pathway (K254001).

openFDA lists it as a Class 2 device under 21 CFR 892.1200. Class II devices are moderate risk and are subject to general and special controls.

Product code KPS covers 26 devices on the FDA AI list. By decision date, this device is #24 of 26 under that code. Spectrum Dynamics Medical, Ltd. has 3 AI-enabled devices on the list, and the Radiology panel accounts for 1,230 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

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