Medical Device Manufacturer · FI , Helsinki

Mvision AI OY - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2024
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Mvision AI OY Radiology ✕
2 devices
1-2 of 2
Cleared Sep 04, 2025
Dose+ (1.0)
K250064 · MUJ
Radiology · 237d
Cleared Oct 18, 2024
Contour+ (MVision AI Segmentation)
K241490 · QKB
Radiology · 147d
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