Data / Medical devices / China / Shenzhen Xpectvision Technology Co., Ltd.
Shenzhen Xpectvision Technology Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 2 510(k) clearances
Shenzhen Xpectvision Technology Co., Ltd. is registered with the FDA (registration 3022107311) in Shenzhen Guangdong, China. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated February 8, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3022107311
- Address
- 1st Floor, Building A31, No.44 Xiangrui 3rd Road Nanshan District, Shenzhen Guangdong, China, 518000
- Owner or operator
- Shenzhen Xpectvision Technology Co., Ltd. (10084490)
- Roles
- Exporter to the US, Manufacturer, Repackager or relabeler
- First device listed
- February 28, 2022
- Registered through
- 2026
- Brand names listed
- Intraoral X-ray Sensor Holder, Model XVH001, Sensor sheath, Model XVC001, XVC002, XVC003, XVC004, XVD2121 Plus, XVD2530, XpectVision, Handheld Dental X-ray System, XVbeam2000
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Chair, Dental, Without Operative Unit | NRU | 1 | Repackager or relabeler | accessdata.fda.gov |
| Holder, Film, X-Ray | EGZ | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| System, X-Ray, Extraoral Source, Digital | MUH | 2 | Manufacturer | accessdata.fda.gov |
| Unit, X-Ray, Extraoral With Timer | EHD | 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 |
|---|---|---|---|---|---|---|
| February 8, 2024 | K233914 | XVbeam2000 | EHD | Substantially Equivalent | Shenzhen Xpectvision Technology Co., Ltd. | accessdata.fda.gov |
| February 17, 2022 | K220277 | Digital Intraoral X-ray Sensor | MUH | Substantially Equivalent | Shenzhen Xpectvision Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Unit, X-Ray, Extraoral With Timer
- All makers of System, X-Ray, Extraoral Source, Digital
- All makers of Holder, Film, X-Ray
- All makers of Chair, Dental, Without Operative Unit
Updated February 8, 2024. 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.