Data / Medical devices / United States / Linatech, LLC
Linatech, LLC: FDA-registered device maker in Sunnyvale, CA, United States, 4 510(k) clearances
Linatech, LLC is registered with the FDA (registration 3007037519) in Sunnyvale, CA, United States. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated April 12, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007037519
- Address
- 1294 Kifer Road, # 705, Sunnyvale, CA, United States, 94086
- Owner or operator
- Linatech, LLC (10024326)
- Roles
- Complaint file establishment
- First device listed
- August 16, 2009
- Registered through
- 2026
- Brand names listed
- TiGRT, VenusX
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | 2 | Complaint file establishment | accessdata.fda.gov |
| System, Planning, Radiation Therapy Treatment | MUJ | 2 | Complaint file establishment | 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.