K250064

Substantially Equivalent

Dose+ (1.0)

Applicant: Mvision AI OY
Product code: MUJ
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 ↗

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