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FDA-cleared K223523

Sonic DL

GE Medical Systems,LLC (GE Healthcare)

Sonic DL is deep-learning MRI reconstruction for highly undersampled or accelerated cardiac acquisitions on compatible GE 1.5T and 3.0T MRI systems for pediatric and adult patients.

Modality
MRI
Anatomy
Heart/Cardiovascular
Decision
2023-05-30
FDA-cleared K213717

AIR Recon DL

GE Medical Systems,LLC (GE Healthcare)

AIR Recon DL is optional integrated GE MRI reconstruction that removes noise and ringing from supported 1.5T, 3T, and 7T acquisitions across all ages and anatomies.

Modality
MRI
Anatomy
Multi-region
Decision
2022-06-08