AccessGUDID - DEVICE: I2C (IBA Image-Guided Therapy Console) (05404013830534)

GUDID

Device Identifier (DI) Information

Brand Name: I2C (IBA Image-Guided Therapy Console)
Version or Model: adaPTinsight
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Ion Beam Applications SA

Primary DI Number: 05404013830534
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 372078154 *Terms of Use

Device Description: Image-Guided Therapy Console

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?
45064	Radiation therapy digital imager	An automated device that is typically mounted on the gantry of a linear accelerator and intended to produce digital images of x-rayed anatomical landmarks to guide radiation treatment (e.g., tracking/targeting tumours). The device may be a digital imaging panel (e.g., of silicon) on robotic arms; it may also have an x-ray source to generate higher quality images.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LHN	System, Radiation Therapy, Charged-Particle, Medical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8fc1d34f-9631-40c9-91ee-ad99f8d4641d
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: February 08, 2018