FDA.reportPublic FDA data

I2C (IBA Image-Guided Therapy Console)

Primary DI
05404013833313
Brand
I2C (IBA Image-Guided Therapy Console)
Company
Ion Beam Applications SA
Model
adaPTinsight
Catalog number
NA
Device description
Image-Guided Therapy Console
Published
2018-02-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
05404013833313PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05404013833313054040138333135404013833313

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850065937007eMotusEMPNIA INC.LHN2026-09-21
00850065937014eMotusEMPNIA INC.LHN2026-09-21
00850065937021eMotusEMPNIA INC.LHN2026-09-21
00850065937038eMotusEMPNIA INC.LHN2026-09-21
00850065937045eMotusEMPNIA INC.LHN2026-09-21
00850065937052eMotusEMPNIA INC.LHN2026-09-21
00850065937069eMotusEMPNIA INC.LHN2026-09-21
00850065937076eMotusEMPNIA INC.LHN2026-09-21
00850065937083eMotusEMPNIA INC.LHN2026-09-21
00850065937090eMotusEMPNIA INC.LHN2026-09-21
00850065937106eMotusEMPNIA INC.LHN2026-09-21
00850065937113eMotusEMPNIA INC.LHN2026-09-21
00850065937120eMotusEMPNIA INC.LHN2026-09-21
00850065937137eMotusEMPNIA INC.LHN2026-09-21
00850065937144eMotusEMPNIA INC.LHN2026-09-21
00850065937151eMotusEMPNIA INC.LHN2026-09-21
00850065937168eMotusEMPNIA INC.LHN2026-09-21
00850065937175eMotusEMPNIA INC.LHN2026-09-21
00850065937182eMotusEMPNIA INC.LHN2026-09-21
00850065937199eMotusEMPNIA INC.LHN2026-09-21
00850065937205eMotusEMPNIA INC.LHN2026-09-21
00850065937212eMotusEMPNIA INC.LHN2026-09-21
00850065937229eMotusEMPNIA INC.LHN2026-09-21
00850065937236eMotusEMPNIA INC.LHN2026-09-21
00850065937243eMotusEMPNIA INC.LHN2026-09-21
00850065937250eMotusEMPNIA INC.LHN2026-09-21
00850065937267eMotusEMPNIA INC.LHN2026-09-21
00850065937274eMotusEMPNIA INC.LHN2026-09-21
00850065937298eMotusEMPNIA INC.LHN2026-09-21
00850065937304eMotusEMPNIA INC.LHN2026-09-21