FDA.reportPublic FDA data

I2C (IBA Image Guided Therapy Console)

Primary DI
05404013831906
Brand
I2C (IBA Image Guided Therapy Console)
Company
Ion Beam Applications SA
Model
adaPTinsight
Catalog number
NA
Device description
Image Guided Therapy Console
Published
2019-09-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LHNSystem, Radiation Therapy, Charged-Particle, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LHNSystem, Radiation Therapy, Charged-Particle, MedicalRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05404013831906PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05404013831906054040138319065404013831906

GMDN Terms#

Term, Definition table
TermDefinition
Radiation therapy digital imagerAn 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
372078154
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05404013801138 IBA Proton Therapy System – Proteus 235Proteus PLUS/Proteus ONE2021-02-28
05404013802012I2C (IBA Image-Guided Therapy Console)adaPTinsight2020-08-09
05404013834013I2C (IBA Image-Guided Therapy Console)adaPTinsight2020-02-03
05404013831333I2C (IBA Image-Guided Therapy Console)adaPTinsight2019-10-08
05404013831258I2C (IBA Image-Guided Therapy Console)adaPTinsight2019-09-26
05404013814015Proteus 235Proteus PLUSNA2018-08-03
05404013810901Proteus 235Proteus PLUSNA2018-01-31
05404013813308Proteus 235Proteus PLUSNA2017-10-23
05404013820504Proteus 235Proteus ONE2017-09-22
05404013821303Proteus 235Proteus ONE2017-09-28
05404013830534I2C (IBA Image-Guided Therapy Console)adaPTinsight2018-02-08
05404013830626I2C (IBA Image-Guided Therapy Console)adaPTinsightNA2017-09-22
05404013830909I2C (IBA Image-Guided Therapy Console)adaPTinsightNA2018-01-31
05404013830916I2C (IBA Image-Guided Therapy Console)adaPTinsight2018-01-31
05404013830923I2C (IBA Image-Guided Therapy Console)adaPTinsightNA2018-01-31
05404013833313I2C (IBA Image-Guided Therapy Console)adaPTinsightNA2018-02-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00864366000148MEVION S250-FIT Proton Therapy SystemMEVION MEDICAL SYSTEMS, INC.LHN2026-05-04
00864366000117MEVION S250-FIT Proton Therapy SystemMEVION MEDICAL SYSTEMS, INC.LHN2026-04-30
00858991006194ProBeam 360 Proton Therapy System - Rotating GantryVarian Medical Systems Particle Therapy GmbH & Co. KGLHN2026-04-29
EPTWTM310220PinPointPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHN2026-04-15
EPTWTN310220PinPointPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHN2026-04-15
EPTWTW310220PinPointPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHN2026-04-15
EPTWTM310240SemiflexPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHN2026-04-14
EPTWTM310250PinPointPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHN2026-04-14
EPTWTN310240SemiflexPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHN2026-04-14
EPTWTN310250PinPointPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHN2026-04-14
EPTWTW310240SemiflexPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHN2026-04-14
EPTWTW310250PinPointPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHN2026-04-14
04560333350334PROBEATHITACHI HIGH-TECH CORPORATIONLHN2026-04-01
04560333350341PROBEATHITACHI HIGH-TECH CORPORATIONLHN2026-04-01
04560333350358PROBEATHITACHI HIGH-TECH CORPORATIONLHN2026-04-01
04560333350365PROBEATHITACHI HIGH-TECH CORPORATIONLHN2026-04-01
04560333350372PROBEATHITACHI HIGH-TECH CORPORATIONLHN2026-04-01
04560333350389PROBEATHITACHI HIGH-TECH CORPORATIONLHN2026-04-01
04560333350396PROBEATHITACHI HIGH-TECH CORPORATIONLHN2026-04-01
04560333350402PROBEATHITACHI HIGH-TECH CORPORATIONLHN2026-04-01
04560333350419PROBEATHITACHI HIGH-TECH CORPORATIONLHN2026-04-01
04560333350426PROBEATHITACHI HIGH-TECH CORPORATIONLHN2026-04-01
04560333350433PROBEATHITACHI HIGH-TECH CORPORATIONLHN2026-04-01
04560333350440PROBEATHITACHI HIGH-TECH CORPORATIONLHN2026-04-01
04560333350457PROBEATHITACHI HIGH-TECH CORPORATIONLHN2026-04-01
04560333350464PROBEATHITACHI HIGH-TECH CORPORATIONLHN2026-04-01
03760290230170SDX SystemDYN'RLHN2026-02-20
03760290230187SDX SystemDYN'RLHN2026-02-20
04560333350280PROBEATHITACHI, LTD.LHN2026-01-20
00841962120456Alta for HexaPODQfixLHN2026-01-14