Data / Medical devices / China / Beijing LinaTech Medical Technology Co. Ltd
Beijing LinaTech Medical Technology Co. Ltd: FDA-registered device maker in Beijing, China, 4 510(k) clearances
Beijing LinaTech Medical Technology Co. Ltd is registered with the FDA (registration 3004580128) in Beijing, China. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated April 12, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3004580128
- Address
- Building 7, No.7 Tongji Middle Road, Beijing Economic-Technological Development Zone, Beijing, China, 10076
- Owner or operator
- Suzhou LinaTech Medical Science and Technology Co.,Ltd. (9063888)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- April 11, 2011
- Registered through
- 2027
- Brand names listed
- TPS, TiGRT, TiGRT IVS, TiGRT MLC, TiGRT DMLC, VenusX
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| System, Planning, Radiation Therapy Treatment | MUJ | 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 |
|---|---|---|---|---|---|---|
| April 12, 2024 | K232489 | VenusX | IYE | Substantially Equivalent | Linatech, LLC | accessdata.fda.gov |
| December 15, 2009 | K092550 | TIGRT IVS | IYE | Substantially Equivalent | Linatech, LLC | accessdata.fda.gov |
| July 15, 2009 | K090893 | TIGRT TPS | MUJ | Substantially Equivalent | Linatech, LLC | accessdata.fda.gov |
| July 7, 2009 | K090802 | TIGRT MLC, TIGRT DMLC | IYE | Substantially Equivalent | Linatech, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Accelerator, Linear, Medical
- All makers of System, Planning, Radiation Therapy Treatment
Updated April 12, 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.