Contour+ (MVision AI Segmentation)— 510(k) K241490

Substantially Equivalent

Mvision AI OY

FDA 510(k) clearance K241490 for Contour+ (MVision AI Segmentation), Substantially Equivalent on 2024-10-18. Applicant: Mvision AI OY. Device class: 2.

Clearance details

Applicant
Mvision AI OY
Product code
Code QKB
Device class
Class 2
Regulation
21 CFR 892.2050
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Helsinki, FI
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