PIUR tUS inside— 510(k) K250484

Substantially Equivalent

Piur Imaging GmbH

FDA 510(k) clearance K250484 for PIUR tUS inside, Substantially Equivalent on 2025-06-30. Applicant: Piur Imaging GmbH. Device class: 2.

Clearance details

Applicant: Piur Imaging GmbH
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2025-02-19
Decision date: 2025-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vienna, AT

Download summary PDF View on FDA.gov ↗

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