Cleared Special

TruSPECT Processing Station

K253532 · Spectrum Dynamics Medical, Ltd. · Radiology

Dec 2025

Decision

47d

Days

Class 2

Risk

About This 510(k) Submission

K253532 is an FDA 510(k) clearance for the TruSPECT Processing Station, a Automated Radiological Image Processing Software (Class II — Special Controls, product code QIH), submitted by Spectrum Dynamics Medical, Ltd. (Caesarea, IL). The FDA issued a Cleared decision on December 30, 2025, 47 days after receiving the submission on November 13, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K253532 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 13, 2025
Decision Date	December 30, 2025
Days to Decision	47 days
Submission Type	Special
Review Panel	Radiology (RA)
Summary	Summary PDF

Device Classification

Product Code	QIH — Automated Radiological Image Processing Software
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 892.2050
Definition	To Provide Automated Radiological Image Processing And Analysis Tools. Software Implementing Artificial Intelligence Including Nonadaptive Machine Learning Algorithms Trained With Clinical And/or Artificial Data. In These Devices, The Algorithm Training Data Typically Impacts Device Performance. Adaptive Ai Algorithms Are Not Within Scope Of This Product Code.