gudid Primary ID: 12 MeV

LIAC (UDI 12 MeV)

Manufactured by S.I.T. SORDINA IORT TECHNOLOGIES SPA

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The LIAC (Model/Catalog Number: 12 MeV) is a medical device manufactured by S.I.T. SORDINA IORT TECHNOLOGIES SPA. This product is indexed under FDA Product Code / Category Classification IYE within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 12 MeV
Product Code / EMDN: IYE
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).
Database Sync Date: 2026-08-09 09:04:28

Full Regulatory Attributes

🔒 Token Gated

{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

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Frequently Asked Questions

Who is the primary manufacturer of LIAC?

The registered manufacturer of record for LIAC is S.I.T. SORDINA IORT TECHNOLOGIES SPA.

What is the Primary UDI-DI identifier for LIAC?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 12 MeV.

What classification code is assigned to this device?

This device is registered under product classification code IYE.

Similar Classification Devices (IYE)

Other Devices by S.I.T. SORDINA IORT TECHNOLOGIES SPA

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