MVision AI Segmentation— 510(k) K212915

Substantially Equivalent

MVision AI

FDA 510(k) clearance K212915 for MVision AI Segmentation, Substantially Equivalent on 2022-05-03. Applicant: MVision AI. Device class: 2.

Clearance details

Applicant
MVision AI
Product code
Product 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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