Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008304180

FEI Number

3008164200

Entity Name

PixxGen Corporation

City/State/Country

Anyang-si Gyeonggi, KR

Establishment Address

5F Smart Bay, 123, Beolmal-ro, Dongan-gu, Anyang-si Gyeonggi 14056, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

PixxGen Corporation (Owner Number: 10035114)

Owner / Operator Contact Address

28081 Hastings, Mission Viejo, CA 92692, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K182533

PMA Number

N/A

All Registered Proprietary Names

PIXX2430 Prudent 1717, Prudent 1417, Prudent 1212 PIXX1717;PIXX1417;PIXX1212

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2019-07-30
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2021-07-05
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2018-12-05

Official Correspondent

John Ross

US Agent Details

JOHN ROSS Business: Private Email: john-ross@msn.com Phone: (949) 9295910

Related Public Records

Same Entity

PixxGen Corporation

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K070563	Vidar Systems Corp.	VIDAR VISION 2000	2007-03-16
K190691	Pixxgen Corporation	Pixx2430 Digital Diagnostic X-Ray Receptor Panel	2019-04-04
K150150	Rayence Co., Ltd.	1717SGN / 1717SCN Digital Flat Panel X-ray Detector	2015-03-27
K140771	Philips Medical Systems Dmc GmbH	PHILIPS ELEVA WORKSPOT	2014-04-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0005-2009	Toshiba American Medical Systems Inc	2	Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or higher software. Controller for Infinix interventional angiography systems.
Z-0031-2007	AGFA Corp.	2	CR DX-S, Image Intensified Fluoroscopic X-ray system.

Similar Registrations

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3038614464	Canon.Inc	OHTA-KU Tokyo, JP
9614698	CANON INC.	OTAWARA-SHI Tochigi, JP
3003775006	FUJIFILM Healthcare Manufacturing Corporation Hanamaki Office	HANAMAKI-SHI Iwate, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008304180. Last updated year: 2026. Please use registration number 3008304180 when referencing this establishment in official correspondence.