FDA.reportPublic FDA data

MatriXX FFF

Primary DI
EIBAE30300150
Brand
MatriXX FFF
Company
IBA Dosimetry GmbH
Model
E3030015
Device description
MatriXX FFF kalibriert
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYEAccelerator, Linear, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K031634000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K031634000OMNIPRO I'MRTWellhofer Dosimetrie2003-08-29IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EIBAE30300151PackageHIBCC1In Commercial Distribution
EIBAE30300150PrimaryHIBCC0

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.

Contacts#

Phone, Email table
PhoneEmail
+1 901 386-2242USService@iba-group.com
+861080809107ServiceAPAC@iba-group.com
+49912860738service@iba-group.com

Regulatory Flags#

DUNS number
332599307
Device count
1
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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840510401368KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-09
00840510401351KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-08
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00841962120517Knee / Elbow Extremity FibreplastQfixIYE2026-06-05
00841962120524Foot Extremity FibreplastQfixIYE2026-06-05
00841962120531Dual Hand / Shoulder Extremity FibreplastQfixIYE2026-06-05
00841439115305MultiFix 2QfixIYE2026-06-04
00841439115312MultiFix 2 - JointGlowQfixIYE2026-06-04
00841439115329Extremity RiserQfixIYE2026-06-04
00841439115336Extremity Riser - JointGlowQfixIYE2026-06-04
00841439115343MultiFix Indexing PostQfixIYE2026-06-04
00840510401320KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-03
00840510401344KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-03
00840510401283KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401290KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401306KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401313KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401337KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401276KLARITY MEDICALKlarity Medical Products, LLCIYE2026-05-29
08057014731224LIAC HWLS.I.T. SORDINA IORT TECHNOLOGIES SPAIYE2026-04-30
08057014731231LIAC HWLS.I.T. SORDINA IORT TECHNOLOGIES SPAIYE2026-04-30
08720168162595Mask DSPS®-PROSH set/5MACROMEDICS B.V.IYE2026-04-23
08720168162564DSPS-Prominent® Cradle-IIMACROMEDICS B.V.IYE2026-04-22
08720168162571Mask DSPS®-PROSHVRL set/5MACROMEDICS B.V.IYE2026-04-22
08720168162618Mask DSPS®-PROSHL set/5MACROMEDICS B.V.IYE2026-04-22
08720168162649Mask DSPS®-PROSHVR set/5MACROMEDICS B.V.IYE2026-04-22
08720168162748Mask DSPS®-PROH, set/5MACROMEDICS B.V.IYE2026-04-22
08720168162755Mask DSPS®-PRO, set/5MACROMEDICS B.V.IYE2026-04-22
08720168162779DSPS-Prominent® Cradle-IIIMACROMEDICS B.V.IYE2026-04-22
08720168162786DSPS-Prominent® Cradle-IVMACROMEDICS B.V.IYE2026-04-22