FDA.reportPublic FDA data

myQA® SRS Phantom Cyberknife

Primary DI
EIBASR020010
Brand
myQA® SRS Phantom Cyberknife
Company
IBA Dosimetry GmbH
Model
SR02001
Catalog number
SR02-001
Device description
myQA® SRS Phantom Cyberknife for myQA SRS detector for SRS and SBRT patient plan verification
Published
2023-10-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IXGPhantom, Anthropomorphic, Radiographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IXGPhantom, Anthropomorphic, RadiographicRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EIBASR020010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 786 288 0369service-usa@iba-group.com
+49912860738service-emea@iba-group.com
+861080809288service-apac@iba-group.com

Regulatory Flags#

DUNS number
332599307
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EIBAE30635000myQA StarTrack³, including Energy Verification Plates and SoftwareE3063500ST03-0002026-04-24
EIBAMQ040000myQA AcceptMQ04-0002016-09-09
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
EIBAE30702000myQA SRS Detector Cyberknife editionE3070200SR01-1002023-07-25
EIBAE30702001myQA SRS Detector Cyberknife editionE3070200SR01-1002023-07-25
EIBAE20702000DOSE-XE2070200DX00-0002023-04-13
EIBAE20703000DOSE-XE2070300DX00-1002023-04-13
EIBABS505000miniPhantomBS50-500BS50-5002023-04-12
EIBABS505001miniPhantomBS50-500BS50-5002023-04-12
EIBAE14000300CCU Steuerelektronik PTE14000302023-04-12
EIBAHA031150Lift tableHA03-115HA03-1152023-04-12
EIBAHA032300Lift tableHA03-230HA03-2302023-04-12
EIBAE30350100"CQA ""StarTrack"""E3035010BS80-000, BS80-010, BS80-1002016-09-09
EIBAM98000000IMRT - Bodyphantom M9800000BS40-0002016-09-09
EIBA120104HSE0KermaX-plus1120-104 HS E2021-12-17
EIBA120104HST0KermaX-plus1120-104 HS T2021-12-17
EIBA120104MICRO0KermaX-plus1120-104 MICRO2021-12-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812266030932Rando®Providus Holdings, Inc.IXG2024-07-11
00812266030949Rando®Providus Holdings, Inc.IXG2024-07-11
00812266030956Rando®Providus Holdings, Inc.IXG2024-07-11
00812266030963Rando®Providus Holdings, Inc.IXG2024-07-11
00812266030970Rando®Providus Holdings, Inc.IXG2024-07-11
00812266030987Rando®Providus Holdings, Inc.IXG2024-07-11
00812266030994Rando®Providus Holdings, Inc.IXG2024-07-11
00812266031007Rando®Providus Holdings, Inc.IXG2024-07-11
06977071930908MeicenGuangdong Meicen Medical Equipment Co., Ltd.IXG2024-06-21
00812266030758LiquiPhil™Providus Holdings, Inc.IXG2024-05-07
00812266030765LiquiPhil™Providus Holdings, Inc.IXG2024-05-07
00812266030772LiquiPhil™Providus Holdings, Inc.IXG2024-05-07
00812266030789LiquiPhil™Providus Holdings, Inc.IXG2024-05-07
00812266030796LiquiPhil™Providus Holdings, Inc.IXG2024-05-07
00812266030802LiquiPhil™Providus Holdings, Inc.IXG2024-05-07
00812266030697LiquiPhil™Providus Holdings, Inc.IXG2024-05-03
00812266030703LiquiPhil™Providus Holdings, Inc.IXG2024-05-03
00812266030710LiquiPhil™Providus Holdings, Inc.IXG2024-05-03
00812266030727LiquiPhil™Providus Holdings, Inc.IXG2024-05-03
00812266030734LiquiPhil™Providus Holdings, Inc.IXG2024-05-03
00812266030741LiquiPhil™Providus Holdings, Inc.IXG2024-05-03
09355529000033T1CMR Phantom (1.5T)RESONANCE HEALTH ANALYSIS SERVICES PTY LTDIXG2024-04-17
09355529000064T1CMR Phantom (3.0T)RESONANCE HEALTH ANALYSIS SERVICES PTY LTDIXG2024-04-17
09355529000071T2CMR PhantomRESONANCE HEALTH ANALYSIS SERVICES PTY LTDIXG2024-04-17
09355529000088R2*/T2* PhantomRESONANCE HEALTH ANALYSIS SERVICES PTY LTDIXG2024-04-17
00812266030673LiquiPhil™Providus Holdings, Inc.IXG2024-03-18
00812266030680LiquiPhil™Providus Holdings, Inc.IXG2024-03-18
00850019946505Standard Imaging Lucy 3D QA PhantomSTANDARD IMAGING INC.IXG2023-06-22
00850019946512Standard Imaging MIMI PhantomSTANDARD IMAGING INC.IXG2023-06-22
00850019946529Standard Imaging Stereotactic Dose Verification PhantomSTANDARD IMAGING INC.IXG2023-06-22