Data / Medical devices / China / Our SMD Medical (wuhan) Co., Ltd.
Our SMD Medical (wuhan) Co., Ltd.: FDA-registered device maker in Wuhan Hubei, China, 2 510(k) clearances
Our SMD Medical (wuhan) Co., Ltd. is registered with the FDA (registration 3020999824) in Wuhan Hubei, China. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated February 4, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3020999824
- 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, China, 430223
- Owner or operator
- OUR SMD Medical (Wuhan) Co., Ltd. (10082948)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer
- First device listed
- October 15, 2021
- Registered through
- 2026
- Brand names listed
- Galaxy RTi, SMD Galaxy RTx, SMD-XGD/AR
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Radiation Therapy, Radionuclide | IWB | 2 | Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer | 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 |
|---|---|---|---|---|---|---|
| February 4, 2020 | K200050 | Akesis Galaxy RTx | IWB | Substantially Equivalent | Akesis, Inc. | accessdata.fda.gov |
| September 4, 2019 | K190844 | Akesis Galaxy | IWB | Substantially Equivalent | Akesis, Inc. | accessdata.fda.gov |
Compare with other makers
Updated February 4, 2020. 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.