FDA.reportPublic FDA data

I2C (IBA Image-Guided Therapy Console)

Primary DI
05404013802012
Brand
I2C (IBA Image-Guided Therapy Console)
Company
Ion Beam Applications SA
Model
adaPTinsight
Device description
Image-Guided Therapy Console
Published
2020-08-09
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
05404013802012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05404013802012054040138020125404013802012

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
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
05404013831906I2C (IBA Image Guided Therapy Console)adaPTinsightNA2019-09-26
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