VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364) +1 more— 510(k) K254001

Name: FDA 510(k) clearance K254001
Creator: U.S. Food and Drug Administration
Published: 2026-01-13

Substantially Equivalent

Spectrum Dynamics Medical, Ltd.

FDA 510(k) clearance K254001 for VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364) +1 more, Substantially Equivalent on 2026-01-13. Applicant: Spectrum Dynamics Medical, Ltd.. Device class: 2.

Clearance details

Device name as filed: VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)
Applicant: Spectrum Dynamics Medical, Ltd.
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2025-12-15
Decision date: 2026-01-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Caesarea, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code KPS

view all

K261305 — MICSI-PET2026-09-11
K261427 — uMI Panvivo (uMI Panvivo M)2026-07-28
K261315 — Symbia Pro.specta Q3 (11364751) +3 more2026-05-21
K260524 — uMI Panvivo (5 models)2026-04-03
K253564 — uMI Panvivo (4 models)2026-02-13

More clearances from Spectrum Dynamics Medical, Ltd.

view all

K253532 — TruSPECT Processing Station2025-12-30
K230600 — VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364) +1 more2023-04-28
K212230 — TruSPECT Radiological Image Processing Station2021-08-16
K190457 — VERITON CT whole body SPECT/CT system2019-07-12
K182484 — VERITON CT whole body SPECT/CT system2018-11-09

Data sourced from openFDA. This site is unofficial and independent of the FDA.