iQ-solutions— 510(k) K231929

Name: FDA 510(k) clearance K231929
Creator: U.S. Food and Drug Administration
Published: 2023-12-18

Substantially Equivalent

Sydney Neuroimaging Analysis Centre Pty, Ltd.

FDA 510(k) clearance K231929 for iQ-solutions, Substantially Equivalent on 2023-12-18. Applicant: Sydney Neuroimaging Analysis Centre Pty, Ltd.. Device class: 2.

Clearance details

Applicant: Sydney Neuroimaging Analysis Centre Pty, Ltd.
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2023-06-30
Decision date: 2023-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Camperdown, AU

Download summary PDF View on FDA.gov ↗

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