Liac
LIAC is intended for use in radiation therapy in the operating theatre on a patient from whom the surgeon has just removed a neoplasia. The device may solely be used for oncological…
LIAC is intended for use in radiation therapy in the operating theatre on a patient from whom the surgeon has just removed a neoplasia. The device may solely be used for oncological radiation therapy. The contraindications are related to use on non-oncological patients. To this end, the mobile structure with its equipment is moved to the patient at the appropriate time and placed in a position such that the applicator can be connected. At this point, the operating theatre is evacuated and the radiation command given from the console outside, after which the mobile structure is removed and surgery completed. The radiation time is normally not more than two minutes and therefore does not significantly affect the surgery time. The machine may only be used by radiation therapy or surgery staff previously trained for its use. In order to reduce the dose to the healthy tissues of the patient during the therapeutic treatment, the specific Abdominal Radiation Protection Screens must be used. The control console normally does not require sterilization but only regular cleaning. LIAC is intended to be used in a public and private health environment. LIAC is intended to be handled by trained personnel (operators)authorised by the user (authority responsible).
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (2), Beijing (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangzhou Tian Hong Medical Technology Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 4 |
| Klarity Medical & Equipment (GZ) Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 3 |
| Elekta Beijing Medical Systems Co., Ltd. | Beijing | Beijing | Contract manufacturer | 1 |
| Manteia Technologies Co., Ltd. | Xiamen | Fujian | Manufacturer | 3 |
| OUR United Corporation | Xian | Shaanxi | Contract manufacturer | 2 |
| Suzhou Linatech Medical Science AND Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 2 |
| Varian Medical Systems China Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
| Jiangsu Rayer Medical Technology Co., Ltd. | Wuxi | Jiangsu | Manufacturer | 1 |
Record
| Listed by | S.I.T. Sordina Iort Technologies SPA |
|---|---|
| FDA product code | IYE |
| Device type | Accelerator, Linear, Medical |
| Device class | Class 2 |
| Regulation | 21 CFR 892.5050 |
| 510(k) | K110840 |
| Record published | 2016-09-12 |
| Record revised | 2026-04-23 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment humidity 30 to 75 % RH; Storage environment temperature 10 to 50 °C; Storage environment humidity 30 to 90 % RH; Handling environment temperature 18 to 25 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10 MeV | 10 MeV | In distribution |
| 12 MeV | 12 MeV | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Klarity Medical | Klarity Medical Products, LLC | 891 |
| Orfit Industries | Orfit Industries NV | 680 |
| Aquaplast RT™ | Qfix | 569 |
| Fibreplast® | Qfix | 271 |
| Bionix Radiation Therapy | Bionix Radiation Therapy, LLC | 115 |
| Vac-Lok™ Cushion | Medtec LLC | 100 |
| Visicoil | IZI Medical Products LLC | 86 |
| BodyFIX | 3C-Medical Intelligence GmbH | 84 |
| AlignRT Plus | Vision RT Limited | 72 |
| Fibreplast® Assure™ Open View | Qfix | 72 |
| Accelerator, Linear, Medical | PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH | 71 |
| Thermoplastic Mask | IZI Medical Products LLC | 58 |
Showing 12 of 1,611. All products under Accelerator, Linear, Medical
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.