AccessGUDID - DEVICE: LIAC (08057014730050)

GUDID

Device Identifier (DI) Information

Brand Name: LIAC
Version or Model: 10 MeV
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 900050001
Company Name: S.I.T. SORDINA IORT TECHNOLOGIES SPA

Primary DI Number: 08057014730050
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 339852325 *Terms of Use

Device 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).

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35159	Linear accelerator system	An assembly of devices designed to produce high-energy electrons to yield high-energy x-rays used for therapeutic applications, primarily to treat cancer. It provides a uniform radiation field of uniform intensity and predictable energy level, in a beam with well defined dimensions. The principle of operation is linear acceleration of electrons by means of electromagnetic (EM) microwaves. The output is used as a treatment beam on the patient, either directly or after passing a suitable target. The system typically includes signal analysis and display devices, patient and device supports, and software.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IYE	Accelerator, Linear, Medical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K110840	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Storage Environment Temperature: between 10 and 50 Degrees Celsius
Storage Environment Humidity: between 30 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between 18 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 10 MeV

Device Record Status

Public Device Record Key: 2d7af7f6-be55-47dc-84c5-0ca695312270
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 12, 2016