Change Healthcare Anatomical AI— 510(k) K210719

Name: FDA 510(k) clearance K210719
Creator: U.S. Food and Drug Administration
Published: 2021-07-20

Substantially Equivalent

Change Healthcare Canada Company

FDA 510(k) clearance K210719 for Change Healthcare Anatomical AI, Substantially Equivalent on 2021-07-20. Applicant: Change Healthcare Canada Company. Device class: 2.

Clearance details

Applicant: Change Healthcare Canada Company
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2021-03-10
Decision date: 2021-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richmond, CA

Download summary PDF View on FDA.gov ↗

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