Suzhou Linatech Medical Science AND Technology Co., Ltd.
Registered establishment in Suzhou, Jiangsu, China. 2 device types.
Suzhou Linatech Medical Science AND Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Accelerator, Linear, Medical, System, Planning, Radiation Therapy Treatment. Its earliest product listing with the FDA dates from 2011.
Registration
| Registered name | SUZHOU LINATECH MEDICAL SCIENCE AND TECHNOLOGY CO.,LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3004580128 |
| FEI number | 3004580128 |
| Establishment type | Manufacturer, Exporter |
Location
| City | Suzhou |
|---|---|
| Province | Jiangsu |
| Address | NO. 3, JIN SHENG ROAD |
| Postal code | 215126 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accelerator, Linear, Medical | Class 2 | TiGRT IVS, TiGRT MLC, TiGRT DMLC, TiGRT, VenusX | 2011 | 8 |
| System, Planning, Radiation Therapy Treatment | Class 2 | TPS | 2011 | 5 |
Clearances
No clearance names Suzhou Linatech Medical Science AND Technology Co., Ltd. as applicant. 4 are held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K232489 | 2024-04-12 | IYE | Traditional | Linatech, LLC |
| K092550 | 2009-12-15 | IYE | Traditional | Linatech, LLC |
| K090893 | 2009-07-15 | MUJ | Traditional | Linatech, LLC |
| K090802 | 2009-07-07 | IYE | Traditional | Linatech, LLC |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1996 |
|---|---|
| Main products | VenusX Medical Linear Accelerator, VenusPlus Medical Linear Accelerator, TiGRT D2SRS Stereotactic Radiotherapy System, TiGRT-TPS Radiotherapy Planning System, TiGRT-IVS Image-Guided Radiotherapy System |
| Certifications | 85 invention patents, 7 PCT patents, 13 Class III medical device registrations, 4 US FDA certifications |
| Export markets | Indonesia, Hong Kong |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.