icobrain aria— 510(k) K240712

Substantially Equivalent

Icometrix NV

FDA 510(k) clearance K240712 for icobrain aria, Substantially Equivalent on 2024-11-07. Applicant: Icometrix NV. Device class: 2.

Clearance details

Applicant: Icometrix NV
Product code: Code QBS
Device class: Class 2
Regulation: 21 CFR 892.2090
Advisory panel: Radiology
Date received: 2024-03-15
Decision date: 2024-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leuven, BE

Download summary PDF View on FDA.gov ↗

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