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FDA-cleared K251153

Aurora

GE Medical Systems Israel

Authorized purpose: Aurora is a SPECT/CT system for nuclear-medicine uptake imaging, standalone CT, anatomical localization, attenuation correction, diagnosis, staging, therapy planning, guidance, and monitoring. K251153 adds deep-learning kidney segmentation to dynamic renal scintigraphy.

Modality
PET/SPECT/Nuclear Medicine
Anatomy
Multi-region
Decision
2025-06-12