Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005136058

FEI Number

3005136058

Entity Name

MASEP MEDICAL SCIENCE & TECHNOLOGY DEVELOPMENT(SHENZHEN)Co.

City/State/Country

SHENZHEN Guangdong, CN

Establishment Address

601 14th Building, Software Yard, Tech Mid Road 2nd, Nanshan District, SHENZHEN Guangdong 518057, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MASEP MEDICAL SCIENCE & TECH.DEVELOPMENT (SHENZHEN (Owner Number: 9063158)

Owner / Operator Contact Address

601, 14Building, SHENZHEN SOFTWARE YARD, Keji ZHONG ER Road, HIGH-TECH ZONE, SHENZHEN, CN-GD 518057, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K102533

PMA Number

N/A

All Registered Proprietary Names

SRRS INFINI

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	2007-12-18
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	Class 2	892.5050	2012-01-29
IWB	System, Radiation Therapy, Radionuclide	Radiology	Class 2	892.5750	2012-01-29

Official Correspondent

Mengzhen Han

US Agent Details

Lucy Li Email: lucyxiaoxia@gmail.com Phone: (949) 5629688

Related Public Records

Same Entity

MASEP MEDICAL SCIENCE & TECH.DEVELOPMENT (SHENZHEN

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
K993675	Nomos Corp.	PEREGRINE RADIATION THERAPY DOSE CALCULATION SYSTEM	2000-09-05

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0014-2012	Elekta, Inc.	2	Dynamic Multileaf Collimator (DMLC) Shapes the radiation beam in treatment therapy.
Z-0038-2017	RAYSEARCH LABORATORIES AB Sveavaegen 9 Stockholm Sweden	2	RayStation 2.5, 3.0, 3.5, 4.0, 4.5, 4.7, 5.0 and 4.3 (InverseArc 1.0) -- Radiation Therapy Treatment Planning System RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs.

Similar Registrations

Registration Number	Establishment Name	Location
3015232217	ELEKTA SOLUTIONS AB	STOCKHOLM, SE
3015621321	Akesis Inc.	Concord, CA, US
3014273653	XCISION MEDICAL SYSTEMS, LLC	Columbia, MD, US
3006946288	Best Theratronics Ltd.	Kanata Ontario, CA
9617016	ELEKTA LIMITED	CRAWLEY West Sussex, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005136058. Last updated year: 2026. Please use registration number 3005136058 when referencing this establishment in official correspondence.