myQA FastTrack

GUDID EIBAMQ002000

IBA Dosimetry GmbH

Accelerator system quality assurance device
Primary Device IDEIBAMQ002000
NIH Device Record Keydcdb6bf1-b355-4b70-be48-2919730574c5
Commercial Distribution StatusIn Commercial Distribution
Brand NamemyQA FastTrack
Version Model NumberMQ00-200
Company DUNS332599307
Company NameIBA Dosimetry GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+861080809107
EmailServiceAPAC@iba-group.com
Phone+861080809107
EmailServiceAPAC@iba-group.com
Phone+861080809107
EmailServiceAPAC@iba-group.com
Phone+861080809107
EmailServiceAPAC@iba-group.com
Phone+861080809107
EmailServiceAPAC@iba-group.com
Phone+861080809107
EmailServiceAPAC@iba-group.com
Phone+861080809107
EmailServiceAPAC@iba-group.com
Phone+861080809107
EmailServiceAPAC@iba-group.com
Phone+861080809107
EmailServiceAPAC@iba-group.com
Phone+861080809107
EmailServiceAPAC@iba-group.com
Phone+861080809107
EmailServiceAPAC@iba-group.com
Phone+861080809107
EmailServiceAPAC@iba-group.com
Phone+861080809107
EmailServiceAPAC@iba-group.com
Phone+861080809107
EmailServiceAPAC@iba-group.com
Phone+861080809107
EmailServiceAPAC@iba-group.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEIBAMQ002000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYEAccelerator, Linear, Medical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-09

Devices Manufactured by IBA Dosimetry GmbH

EIBASR020010 - myQA® SRS Phantom Cyberknife2023-10-18 myQA® SRS Phantom Cyberknife for myQA SRS detector for SRS and SBRT patient plan verification
EIBAHA03000V0040 - Lift table2023-09-27 Electric Lift Table Type 230V
EIBAHA03010V0040 - Lift table2023-09-27 Electric Lift Table Type 115V
EIBAHA050000 - Water Reservoir2023-08-11 Waterreservoir - bidirectional pump, 230V
EIBAHA050100 - Water Reservoir2023-08-11 Waterreservoir - bidirectional pump, 115V
EIBAE30702001 - myQA SRS Detector Cyberknife edition2023-08-02 myQA SRS Cyberknife edition
EIBAE20702000 - DOSE-X2023-04-21 DOSE-X Dosimeter TNC
EIBAE20703000 - DOSE-X2023-04-21 DOSE-X Dosimeter BNC

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