FDA.report

Blue Phantom Helix 3D Water Phantom

Primary DI
EIBAM10145000
Brand
Blue Phantom Helix 3D Water Phantom
Company
IBA Dosimetry GmbH
Model
M1014500
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
IYEAccelerator, Linear, Medical

Product Code Classifications

CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
EIBAM10145000PrimaryHIBCC0

GMDN Terms

TermDefinition
Accelerator system quality assurance deviceAn instrument specifically designed to be used to check the calibration and performance of linear and non-linear medical accelerator systems used for radiation therapy applications, for quality assurance (QA) purposes. It includes a variety of instruments used to measure parameters associated with particle and photon beam production, beam quality, and other system performance parameters.

Sterilization Methods

Method

Contacts

PhoneEmail
+861080809107ServiceAPAC@iba-group.com

Regulatory Flags

DUNS number
332599307
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
EIBASR020010myQA® SRS Phantom CyberknifeSR02001SR02-0012023-10-10
EIBAHA03000V0040Lift tableHA03-000#004HA03-000#0042023-09-19
EIBAHA03010V0040Lift tableHA03-010#004HA03-010#0042023-09-19
EIBAHA050000Water ReservoirHA05-000HA05-0002023-08-03
EIBAHA050100Water ReservoirHA05-010HA05-0102023-08-03
EIBAE30702001myQA SRS Detector Cyberknife editionE3070200SR01-1002023-07-25
EIBAE20702000DOSE-XE2070200DX00-0002023-04-13
EIBAE20703000DOSE-XE2070300DX00-1002023-04-13
EIBABS505001miniPhantomBS50-500BS50-5002023-04-12
EIBAE14000300CCU Steuerelektronik PTE14000302023-04-12
EIBAHA031150Lift tableHA03-115HA03-1152023-04-12
EIBAHA032300Lift tableHA03-230HA03-2302023-04-12
EIBA120104HS0KermaX-plus1120-104 HS2021-12-17
EIBA120104HSE1KermaX-plus1120-104 HS E2021-12-17
EIBA120104HST1KermaX-plus1120-104 HS T2021-12-17
EIBA120104MICRO1KermaX-plus1120-104 MICRO2021-12-17
EIBA120104TINO1KermaX-plus1120-104 TINO2021-12-17
EIBA120121C1KermaX-plus1120-121C2021-12-17
EIBA120121CPLENO1KermaX-plus1120-121CPLENO 2021-12-17
EIBA120122C1KermaX-plus1120-122C2021-12-17

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