LIAC - LIAC is intended for use in radiation therapy in - S.I.T. SORDINA IORT TECHNOLOGIES SPA

Duns Number:339852325

Device Description: LIAC is intended for use in radiation therapy in the operating theatre on a patient from w 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).

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More Product Details

Catalog Number

900050002

Brand Name

LIAC

Version/Model Number

12 MeV

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K110840

Product Code Details

Product Code

IYE

Product Code Name

Accelerator, Linear, Medical

Device Record Status

Public Device Record Key

23435bf4-11bb-407f-bffb-82eeebaeadbe

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 12, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"S.I.T. SORDINA IORT TECHNOLOGIES SPA" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 9