TruSPECT Processing Station— 510(k) K253532

Name: FDA 510(k) clearance K253532
Creator: U.S. Food and Drug Administration
Published: 2025-12-30

Substantially Equivalent

Spectrum Dynamics Medical, Ltd.

FDA 510(k) clearance K253532 for TruSPECT Processing Station, Substantially Equivalent on 2025-12-30. Applicant: Spectrum Dynamics Medical, Ltd.. Device class: 2.

Clearance details

Applicant: Spectrum Dynamics Medical, Ltd.
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2025-11-13
Decision date: 2025-12-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Caesarea, IL

Download summary PDF View on FDA.gov ↗

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More clearances from Spectrum Dynamics Medical, Ltd.

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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.