Data / Medical devices / China / MASEP MEDICAL SCIENCE & TECHNOLOGY DEVELOPMENT(SHENZHEN)Co.
MASEP MEDICAL SCIENCE & TECHNOLOGY DEVELOPMENT(SHENZHEN)Co.: FDA-registered device maker in SHENZHEN Guangdong, China, 2 510(k) clearances
MASEP MEDICAL SCIENCE & TECHNOLOGY DEVELOPMENT(SHENZHEN)Co. is registered with the FDA (registration 3005136058) in SHENZHEN Guangdong, China. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 22, 2011. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005136058
- Address
- 601 14th Building, Software Yard, Tech Mid Road 2nd Nanshan District, SHENZHEN Guangdong, China, 518057
- Owner or operator
- MASEP MEDICAL SCIENCE & TECH.DEVELOPMENT (SHENZHEN (9063158)
- Roles
- Manufacturer
- First device listed
- December 18, 2007
- Registered through
- 2026
- Brand names listed
- INFINI, SRRS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Planning, Radiation Therapy Treatment | MUJ | 2 | Manufacturer | accessdata.fda.gov |
| System, Radiation Therapy, Radionuclide | IWB | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 22, 2011 | K102533 | ROTATING GAMMA SYSTEM INFINI (INFINI) | IWB | Substantially Equivalent | Masep Medical Science & Tech.Development (Shenzhen | accessdata.fda.gov |
| December 30, 2004 | K041125 | MASEP SRRS GAMMA RAYS STEREOTACTIC RADIATION THERAPY SYSTEM FOR HEADS (MASEP GAMMA THERAPY SYSTEM) | IWB | Substantially Equivalent | Masep Med Science & Tech. Development (Shenzhen) C | accessdata.fda.gov |
Compare with other makers
- All makers of System, Radiation Therapy, Radionuclide
- All makers of System, Planning, Radiation Therapy Treatment
Updated March 22, 2011. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.