Identity
- Trade Name
- LIAC FDA UDI
- Generic Name
- Linear accelerator system FDA UDI
- Device Name
- 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). FDA UDI
- Model / Reference
- 10 MeV FDA UDI
- Description
- 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). FDA UDI
Identifiers
- Catalog Number
- 900050001 FDA UDI
- Primary DI / UDI-DI
- 08057014730050 FDA UDI
- 510(k) Number
- K110840 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- Linear accelerator system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Linear accelerator system
Liac by Sit Sordina Iort Technologies Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K110840 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Sit Sordina Iort Technologies Spa
Sources (1)
- FDA UDI 2d7af7f6-be55-47dc-84c5-0ca695312270 38 fields · synced May 30, 2026