InVision Precision LVEF (LVEF)— 510(k) K232331

Name: FDA 510(k) clearance K232331
Creator: U.S. Food and Drug Administration
Published: 2024-04-25

Substantially Equivalent

InVision Medical Technology Corporation

FDA 510(k) clearance K232331 for InVision Precision LVEF (LVEF), Substantially Equivalent on 2024-04-25. Applicant: InVision Medical Technology Corporation. Device class: 2.

Clearance details

Applicant: InVision Medical Technology Corporation
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2023-08-04
Decision date: 2024-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

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