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FDA-cleared K260265

MAGNETOM Flow.Ace; MAGNETOM Flow.Plus

Siemens Shenzhen Magnetic Resonance, Ltd.

Authorized purpose: MAGNETOM Flow.Ace and Flow.Plus are diagnostic MR systems that produce transverse, sagittal, coronal, and oblique images, spectroscopic images and spectra, and labeled information about internal structure and function.

Modality
MRI
Anatomy
Head, body, and extremities
Decision
2026-02-23
FDA-cleared K251822

MAGNETOM Free.Max; MAGNETOM Free.Star

Siemens Shenzhen Magnetic Resonance, Ltd.

Authorized purpose: MAGNETOM Free.Max and Free.Star with syngo MR XA80A are 0.55T MRI systems for broad imaging and compatible interventions; this release adds dentomaxillofacial coil and assist functions plus reconstruction and energy-mode updates.

Modality
MRI
Anatomy
Multi-region
Decision
2025-11-20
FDA-cleared K250436

MAGNETOM Flow.Ace; MAGNETOM Flow.Plus

Siemens Shenzhen Magnetic Resonance, Ltd.

Authorized purpose: MAGNETOM Flow.Ace and Flow.Plus are diagnostic MR systems that produce transverse, sagittal, coronal, and oblique cross-sectional images, spectroscopic images and spectra, and information about internal structure and function for trained physician interpretation.

Modality
MRI
Anatomy
Head, body, and extremities
Decision
2025-06-16