PRO-DOSE System— 510(k) K250083

Substantially Equivalent

Nu-Rise, SA

FDA 510(k) clearance K250083 for PRO-DOSE System, Substantially Equivalent on 2025-10-01. Applicant: Nu-Rise, SA.

Clearance details

Applicant: Nu-Rise, SA
Product code: Code NZT
Advisory panel: Radiology
Date received: 2025-01-13
Decision date: 2025-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ilhavo, PT

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