DASI Dimensions (V1.0)— 510(k) K231324

Substantially Equivalent

Dasi Simulations

FDA 510(k) clearance K231324 for DASI Dimensions (V1.0), Substantially Equivalent on 2024-01-08. Applicant: Dasi Simulations. Device class: 2.

Clearance details

Applicant: Dasi Simulations
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2023-05-08
Decision date: 2024-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dublin, OH, US

Download summary PDF View on FDA.gov ↗

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