FDA-cleared K252379
AIR Recon DL
Ge Medical Systems, LLC
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-12-23
FDA-cleared profile
MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise
Image analysis/processing.
Buyer-fit notes
MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise is best reviewed for MRI teams evaluating mri workflow tools with FDA source traceability.
Not ideal for buyers who need public price benchmarks before vendor contact or teams requiring confirmed deployment details before shortlist review.
FDA and evidence source ledger
Clinical use
Image analysis/processing.
Alternatives
Related tools to compare
FDA-cleared K252670
Alzevita
TOPIA MEDTECH LIMITED
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-12-19
FDA-cleared K253489
Swoop® Portable MR Imaging® System
Hyperfine, Inc.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-12-12
FDA-cleared K251822
MAGNETOM Free.Max; MAGNETOM Free.Star
Siemens Shenzhen Magnetic Resonance , Ltd.
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-11-20