Data / Medical devices / China / Suzhou Powersite Electric Co., Ltd.
Suzhou Powersite Electric Co., Ltd.: FDA-registered device maker in Suzhou Jiangsu, China, 1 510(k) clearance
Suzhou Powersite Electric Co., Ltd. is registered with the FDA (registration 3018269927) in Suzhou Jiangsu, China. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 1, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3018269927
- Address
- Floor 1st, 2nd, 4th, Building 5, No.188 Fuchunjiang Road Suzhou New District, 215151 Suzhou, People's Republic of China, Suzhou Jiangsu, China, 215151
- Owner or operator
- Suzhou Powersite Electric Co., Ltd. (10080411)
- Roles
- Manufacturer
- First device listed
- February 1, 2021
- Registered through
- 2026
- Brand names listed
- Combined High Frequency X-ray Source, Mammographic X-ray High Frequency High Voltage Generator PSG-MG Series, Medical X-ray Computed Tomography High Voltage Generator PSG-CT Series, Medical X-ray High Frequency High Voltage Generator PSG-HR Series, Medical X-ray Radiography Fluoroscopy High Frequency High Voltage Generator PSG-RF Series, Mobile Medical X-ray High Frequency High Voltage Generator PSG-M Series, Mobile X-ray Radiographic Fluoroscopic High Frequency High Voltage Generator PSG-MF Series
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Generator, High-Voltage, X-Ray, Diagnostic | IZO | 1 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Mobile | IZL | 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 |
|---|---|---|---|---|---|---|
| November 1, 2022 | K222258 | Combined High Frequency X-ray Source | IZL | Substantially Equivalent | Suzhou Powersite Electric Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated November 1, 2022. 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.