QOCA image Smart CXR Image Processing System— 510(k) K221868

Name: FDA 510(k) clearance K221868
Creator: U.S. Food and Drug Administration
Published: 2023-01-27

Substantially Equivalent

Quanta Computer, Inc.

FDA 510(k) clearance K221868 for QOCA image Smart CXR Image Processing System, Substantially Equivalent on 2023-01-27. Applicant: Quanta Computer, Inc.. Device class: 2.

Clearance details

Applicant: Quanta Computer, Inc.
Product code: Code QFM
Device class: Class 2
Regulation: 21 CFR 892.2080
Advisory panel: Radiology
Date received: 2022-06-27
Decision date: 2023-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taoyuan City, TW

Download summary PDF View on FDA.gov ↗

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