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FDA-cleared K233728

SIGNA Champion

GE Healthcare (Tianjin) Company Limited

Authorized purpose: The SIGNA Champion is a whole-body magnetic resonance scanner indicated to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, spectra, and dynamic images of structures or functions of the body for trained-physician interpretation that may assist diagnosis. Contrast agents may be used depending on the region.

Modality
MRI
Anatomy
Head, neck, temporomandibular joint, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body
Decision
2024-01-19
FDA-cleared K223439

SIGNA Victor

GE Healthcare (Tianjin) Company Limited

Authorized purpose: SIGNA Victor is a whole-body magnetic-resonance scanner for high-resolution imaging, high signal-to-noise ratio, and short scan times. It is indicated to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, spectra, and dynamic images of structures or functions of the entire body, including head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions. Contrast agents may be used depending on the region, and trained physicians interpret the images.

Modality
MRI
Anatomy
Entire body including head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions
Decision
2023-02-13
FDA-cleared K213603

SIGNA Artist Evo

GE Healthcare(Tianjin) Company Limited

Authorized purpose: SIGNA Artist Evo is a diagnostic MR system for acquisition, reconstruction, display, and professional interpretation within the labeled scanner, coil, sequence, and anatomy scope.

Modality
MRI
Anatomy
Multi-region
Decision
2022-02-11
FDA-cleared K211980

SIGNA Prime

GE Healthcare (Tianjin) Company Limited

Authorized purpose: SIGNA Prime is a whole-body 1.5T MR system for qualified technologists and interpreting physicians to acquire, reconstruct, display, and export labeled diagnostic MR examinations using supported coils, sequences, and applications.

Modality
MRI
Anatomy
Multi-region
Decision
2022-01-16
FDA-cleared K202238

SIGNA Artist

GE Healthcare (Tianjin) Company Limited

Authorized purpose: SIGNA Artist is a 1.5T whole-body MRI system; K202238 adds AIR Recon DL reconstruction to reduce noise and ringing and support improved image quality or shorter acquisitions.

Modality
MRI
Anatomy
Multi-region
Decision
2020-09-04