PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels— 510(k) K180976

Name: FDA 510(k) clearance K180976
Creator: U.S. Food and Drug Administration
Published: 2018-05-24

Substantially Equivalent

Pixxgen Corporation

FDA 510(k) clearance K180976 for PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels, Substantially Equivalent on 2018-05-24. 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: 2018-04-13
Decision date: 2018-05-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anyang-Si, KR

Download summary PDF View on FDA.gov ↗

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