Solid State X-ray Imager(Model: FXRD-4386WB)— 510(k) K220239

Name: FDA 510(k) clearance K220239
Creator: U.S. Food and Drug Administration
Published: 2022-09-13

Substantially Equivalent

Vieworks Co., Ltd.

FDA 510(k) clearance K220239 for Solid State X-ray Imager(Model: FXRD-4386WB), Substantially Equivalent on 2022-09-13. Applicant: Vieworks Co., Ltd.. Device class: 2.

Clearance details

Applicant: Vieworks Co., Ltd.
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2022-01-28
Decision date: 2022-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anyang-Si, KR

Download summary PDF View on FDA.gov ↗

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