FDA-cleared K201369
AVA (Augmented Vascular Analysis)
See-Mode Technologies Pte. Ltd.
Image analysis/processing for Vascular using MRI.
- Modality
- MRI
- Anatomy
- Vascular
- Decision
- 2020-09-16
FDA-cleared profile
Arterys Cardio DL
The device is intended to visualize and quantify MRI data in DICOM format.
Buyer-fit notes
Arterys Cardio DL is best reviewed for MRI Vascular teams evaluating quantification and segmentation tools with FDA source traceability.
Not ideal for buyers who need public price benchmarks before vendor contact.
FDA and evidence source ledger
Clinical use
The device is intended to visualize and quantify MRI data in DICOM format.
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