FDA-cleared K202238

SIGNA Artist

GE Healthcare (Tianjin) Company Limited

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2020-09-04
FDA-cleared K211980

SIGNA Prime

GE Healthcare (Tianjin) Company Limited

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2022-01-16
FDA-cleared K213603

SIGNA Artist Evo

GE Healthcare(Tianjin) Company Limited

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2022-02-11
FDA-cleared K223439

SIGNA Victor

GE Healthcare (Tianjin) Company Limited

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2023-02-13
FDA-cleared K233728

SIGNA Champion

GE Healthcare (Tianjin) Company Limited

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2024-01-19