Pixx2430 Digital Diagnostic X-Ray Receptor Panel— 510(k) K190691

Name: FDA 510(k) clearance K190691
Creator: U.S. Food and Drug Administration
Published: 2019-04-04

Substantially Equivalent

Pixxgen Corporation

FDA 510(k) clearance K190691 for Pixx2430 Digital Diagnostic X-Ray Receptor Panel, Substantially Equivalent on 2019-04-04. Applicant: Pixxgen Corporation. Device class: 2.

Clearance details

Applicant: Pixxgen Corporation
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2019-03-18
Decision date: 2019-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anyang-Si,, KR

Download summary PDF View on FDA.gov ↗

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