I2C (IBA Image-Guided Therapy Console)

GUDID 05404013834013

Image-Guided Therapy Console

Ion Beam Applications SA

Radiation therapy digital imager
Primary Device ID05404013834013
NIH Device Record Keydce6233c-3873-4c5e-acbf-0e9fa940b415
Commercial Distribution StatusIn Commercial Distribution
Brand NameI2C (IBA Image-Guided Therapy Console)
Version Model NumberadaPTinsight
Company DUNS372078154
Company NameIon Beam Applications SA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105404013834013 [Primary]

FDA Product Code

LHNSystem, Radiation Therapy, Charged-Particle, Medical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-11
Device Publish Date2020-02-03

On-Brand Devices [I2C (IBA Image-Guided Therapy Console)]

05404013833313Image-Guided Therapy Console
05404013830923Image-Guided Therapy Console
05404013830916Image-Guided Therapy Console
05404013830909Image-Guided Therapy Console
05404013830626Image-Guided Therapy Console
05404013830534Image-Guided Therapy Console
05404013831258Image-Guided Therapy Console
05404013834013Image-Guided Therapy Console

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