Spectrum Dynamics Medical, Ltd. radiology AI products

FDA-cleared K254001

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

Spectrum Dynamics Medical, Ltd.

VERITON CT 300/400 Series combines SPECT and CT for detection, localization, diagnosis, staging, restaging, organ-function assessment, therapy planning, guidance, and monitoring....

Modality: PET/SPECT/Nuclear Medicine
Anatomy: Multi-region
Decision: 2026-01-13

Detection and CADe Nuclear medicine

FDA-cleared K253532

TruSPECT Processing Station

Spectrum Dynamics Medical, Ltd.

TruSPECT Processing Station receives, transfers, displays, stores, and processes radioisotope-tracer images for trained professionals; TruClear AI SPECT enhancement supports the...

Modality: PET/SPECT/Nuclear Medicine
Anatomy: Heart, organs, and body regions represented in SPECT studies
Decision: 2025-12-30

Cardiac imaging Nuclear medicine

FDA-cleared K212230

TruSPECT Radiological Image Processing Station

Spectrum Dynamics Medical Ltd

TruSPECT Radiological Image Processing Station receives, transfers, displays, stores, and processes radioisotope-tracer images for trained professionals in the labeled SPECT...

Modality: PET/SPECT/Nuclear Medicine
Anatomy: Heart and other organs represented in SPECT studies
Decision: 2021-08-16

Cardiac imaging Nuclear medicine