myQA® SRS Detector

GUDID EIBAE30701001

myQA SRS Detector for SRS/SBRT pre-treatment patient plan verification.

IBA Dosimetry GmbH

Accelerator system quality assurance device

• Primary Device ID: EIBAE30701001
• NIH Device Record Key: f05c5472-9bba-4f7d-8f1b-bb86afea87dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: myQA® SRS Detector
• Version Model Number: E3070100
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +49912860738
• Email: service@iba-group.com
• Phone: +49912860738
• Email: service@iba-group.com
• Phone: +49912860738
• Email: service@iba-group.com
• Phone: +49912860738
• Email: service@iba-group.com
• Phone: +49912860738
• Email: service@iba-group.com
• Phone: +49912860738
• Email: service@iba-group.com
• Phone: +49912860738
• Email: service@iba-group.com
• Phone: +49912860738
• Email: service@iba-group.com
• Phone: +49912860738
• Email: service@iba-group.com
• Phone: +49912860738
• Email: service@iba-group.com
• Phone: +49912860738
• Email: service@iba-group.com
• Phone: +49912860738
• Email: service@iba-group.com
• Phone: +49912860738
• Email: service@iba-group.com
• Phone: +49912860738
• Email: service@iba-group.com
• Phone: +49912860738
• Email: service@iba-group.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EIBAE30701000 [Primary]
HIBCC	EIBAE30701001 [Package]; Contains: EIBAE30701000; Package: Carry Case [1 Units]; In Commercial Distribution

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-15
• Device Publish Date: 2021-04-07

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