Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018269927

FEI Number

3018269927

Entity Name

SUZHOU POWERSITE ELECTRIC CO., LTD.

City/State/Country

Suzhou Jiangsu, CN

Establishment Address

Floor 1st, 2nd, 4th, Building 5, No.188 Fuchunjiang Road, Suzhou New District, 215151 Suzhou, People's Republic of China, Suzhou Jiangsu 215151, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Suzhou Powersite Electric Co., Ltd. (Owner Number: 10080411)

Owner / Operator Contact Address

Building 5, No.188 Fuchunjiang Road, Suzhou New District, 215151 Suzhou, China, Suzhou, CN-JS 215000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K222258

PMA Number

N/A

All Registered Proprietary Names

Combined High Frequency X-ray Source

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2022-11-23

Official Correspondent

Xiaojun Shao

US Agent Details

LIQIN Wang Email: Zhirui_service@163.Com Phone: (908) 3975984

Related Public Records

Same Entity

Suzhou Powersite Electric Co., Ltd.

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
K153059	Minxray, Inc.	HF1202H PowerPlus Portable X-ray Equipment	2016-02-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-1470-2023	FUJIFILM Healthcare Americas Corporation	2	FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams
Z-3158-2024	FUJIFILM Healthcare Americas Corporation	2	The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE) family of digital x-ray detectors coupled.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018269927. Last updated year: 2026. Please use registration number 3018269927 when referencing this establishment in official correspondence.