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
SIS Software
SIS Software is an application intended for use in the viewing, presentation and documentation of medical imaging, including different modules for image processing, image fusion, and intraoperative functional planning where the 3D output can be used with stereotactic image guided surgery or other devices for further...
Buyer-fit notes
SIS Software 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
SIS Software is an application intended for use in the viewing, presentation and documentation of medical imaging, including different modules for image processing, image fusion, and intraoperative functional planning where the 3D output can be used with stereotactic image guided surgery or other devices for further...
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 K252838
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
Siemens Healthcare GmbH
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