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
Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR
Image analysis/processing.
Buyer-fit notes
Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR 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.
FDA and evidence source ledger
Clinical use
Image analysis/processing.
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Image analysis/processing.
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