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
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