510(k) K253532

TruSPECT Processing Station by Spectrum Dynamics Medical, Ltd. — Product Code QIH

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 30, 2025
Date Received: November 13, 2025
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Automated Radiological Image Processing Software
Device Class: Class II
Regulation Number: 892.2050
Review Panel: RA
Submission Type

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.

Other clearances by Spectrum Dynamics Medical, Ltd.

K254001 — VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 4 (January 13, 2026)
K230600 — VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 4 (April 28, 2023)
K212230 — TruSPECT Radiological Image Processing Station (August 16, 2021)
K190457 — VERITON CT whole body SPECT/CT system (July 12, 2019)
K182484 — VERITON CT whole body SPECT/CT system (November 9, 2018)
K180514 — VERITON NM (April 25, 2018)
K161740 — D-SPECT Scanner, D-SPECT L Scanner (November 4, 2016)

Other clearances for product code QIH

K252261 — InferCare RECIST (March 13, 2026)
K252538 — CEPHX3D (March 5, 2026)
K253593 — Clarius Ejection Fraction AI (March 2, 2026)
K253535 — Ligence Heart (February 27, 2026)
K260217 — AI Platform 2.2 (AIP002) (February 24, 2026)
K252084 — AI4CMR v2.0 (February 11, 2026)
K254016 — MI View&GO (February 10, 2026)
K252091 — Surgical Reality Viewer (January 29, 2026)
K252496 — Neurophet AQUA AD Plus (January 29, 2026)
K253735 — AV Vascular (January 22, 2026)