myQA FastTrack

GUDID EIBAMQ002000

IBA Dosimetry GmbH

Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device

• Primary Device ID: EIBAMQ002000
• NIH Device Record Key: dcdb6bf1-b355-4b70-be48-2919730574c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: myQA FastTrack
• Version Model Number: MQ00-200
• Company DUNS: 332599307
• Company Name: IBA Dosimetry GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +861080809107
• Email: ServiceAPAC@iba-group.com
• Phone: +861080809107
• Email: ServiceAPAC@iba-group.com
• Phone: +861080809107
• Email: ServiceAPAC@iba-group.com
• Phone: +861080809107
• Email: ServiceAPAC@iba-group.com
• Phone: +861080809107
• Email: ServiceAPAC@iba-group.com
• Phone: +861080809107
• Email: ServiceAPAC@iba-group.com
• Phone: +861080809107
• Email: ServiceAPAC@iba-group.com
• Phone: +861080809107
• Email: ServiceAPAC@iba-group.com
• Phone: +861080809107
• Email: ServiceAPAC@iba-group.com
• Phone: +861080809107
• Email: ServiceAPAC@iba-group.com
• Phone: +861080809107
• Email: ServiceAPAC@iba-group.com
• Phone: +861080809107
• Email: ServiceAPAC@iba-group.com
• Phone: +861080809107
• Email: ServiceAPAC@iba-group.com
• Phone: +861080809107
• Email: ServiceAPAC@iba-group.com
• Phone: +861080809107
• Email: ServiceAPAC@iba-group.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EIBAMQ002000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031634

FDA Product Code

• IYE: Accelerator, Linear, Medical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-09

Devices Manufactured by IBA Dosimetry GmbH

• EIBASR020010 - myQA® SRS Phantom Cyberknife: 2023-10-18 myQA® SRS Phantom Cyberknife for myQA SRS detector for SRS and SBRT patient plan verification
• EIBAHA03000V0040 - Lift table: 2023-09-27 Electric Lift Table Type 230V
• EIBAHA03010V0040 - Lift table: 2023-09-27 Electric Lift Table Type 115V
• EIBAHA050000 - Water Reservoir: 2023-08-11 Waterreservoir - bidirectional pump, 230V
• EIBAHA050100 - Water Reservoir: 2023-08-11 Waterreservoir - bidirectional pump, 115V
• EIBAE30702001 - myQA SRS Detector Cyberknife edition: 2023-08-02 myQA SRS Cyberknife edition
• EIBAE20702000 - DOSE-X: 2023-04-21 DOSE-X Dosimeter TNC
• EIBAE20703000 - DOSE-X: 2023-04-21 DOSE-X Dosimeter BNC