Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3020999824

FEI Number

3020999824

Entity Name

OUR SMD MEDICAL (WUHAN) CO., LTD.

City/State/Country

Wuhan Hubei, CN

Establishment Address

No. 1, 2, 3 & 4, F1, Block B21, High-tech Medical Devices Park, No.818 Gaoxin Ave.,, East Lake High-tech Development, Wuhan Hubei 430223, CN

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

OUR SMD Medical (Wuhan) Co., Ltd. (Owner Number: 10082948)

Owner / Operator Contact Address

No. 3 & 4, F1, Block B21, High-tech Medical Devices Park, No.818 Gaoxin Ave., East Lake High-tech Development, Wuhan, CN-HB 430223, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K190844

PMA Number

N/A

All Registered Proprietary Names

Galaxy RTi SMD-XGD/AR

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IWB	System, Radiation Therapy, Radionuclide	Radiology	Class 2	892.5750	2025-06-03
IWB	System, Radiation Therapy, Radionuclide	Radiology	Class 2	892.5750	2021-10-15

Official Correspondent

No official correspondent registered.

US Agent Details

Lien pham Business: Akesis Inc. Email: lien.pham@akesis.com Phone: (925) 3498782

Related Public Records

Same Entity

OUR SMD Medical (Wuhan) Co., Ltd.

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3015232217	ELEKTA SOLUTIONS AB	STOCKHOLM, SE
3015621321	Akesis Inc.	Concord, CA, US
3005136058	MASEP MEDICAL SCIENCE & TECHNOLOGY DEVELOPMENT(SHENZHEN)Co.	SHENZHEN Guangdong, CN
3014273653	XCISION MEDICAL SYSTEMS, LLC	Columbia, MD, US
3006946288	Best Theratronics Ltd.	Kanata Ontario, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3020999824. Last updated year: 2026. Please use registration number 3020999824 when referencing this establishment in official correspondence.