Dose+ (1.0)— 510(k) K250064

Substantially Equivalent

Mvision AI OY

FDA 510(k) clearance K250064 for Dose+ (1.0), Substantially Equivalent on 2025-09-04. Applicant: Mvision AI OY. Device class: 2.

Clearance details

Applicant: Mvision AI OY
Product code: Code MUJ
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2025-01-10
Decision date: 2025-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Helsinki, FI

Download summary PDF View on FDA.gov ↗

Recent devices under product code MUJ

K260750 — Virtual Cone (1.0)2026-07-08
K253050 — RadOncAI2026-06-18
K260207 — Multimodality Simulation Workspace (MM Sim) (v1.0.0)2026-05-27
K252784 — eXaSkin Plus2026-05-22
K253078 — ART.1-US2026-05-14

More clearances from Mvision AI OY

K241490 — Contour+ (MVision AI Segmentation)2024-10-18

Data sourced from openFDA. This site is unofficial and independent of the FDA.