QIR Suite— 510(k) K211611

Name: FDA 510(k) clearance K211611
Creator: U.S. Food and Drug Administration
Published: 2022-09-30

Substantially Equivalent

Casis Cardiac Simulation & Imaging Software

FDA 510(k) clearance K211611 for QIR Suite, Substantially Equivalent on 2022-09-30. Applicant: Casis Cardiac Simulation & Imaging Software. Device class: 2.

Clearance details

Applicant: Casis Cardiac Simulation & Imaging Software
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2021-05-25
Decision date: 2022-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Quetigny, FR

Download summary PDF View on FDA.gov ↗

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