Stradivarius™ RT-4558KV4

GUDID 00841962119689

Compression Paddle for Stradivarius SBRT System

Qfix

Indexed-immobilization patient positioning system

• Primary Device ID: 00841962119689
• NIH Device Record Key: 0bb8b6f1-b225-4747-a605-194b79a1c77e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stradivarius™
• Version Model Number: RT-4558KV4
• Catalog Number: RT-4558KV4
• Company DUNS: 808875397
• Company Name: Qfix
• 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: true
• Serial Number: false
• Manufacturing Date: true
• 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: 800-842-8688
• Email: regulatory@cqmedical.com
• Phone: 800-842-8688
• Email: regulatory@cqmedical.com
• Phone: 800-842-8688
• Email: regulatory@cqmedical.com
• Phone: 800-842-8688
• Email: regulatory@cqmedical.com
• Phone: 800-842-8688
• Email: regulatory@cqmedical.com
• Phone: 800-842-8688
• Email: regulatory@cqmedical.com
• Phone: 800-842-8688
• Email: regulatory@cqmedical.com
• Phone: 800-842-8688
• Email: regulatory@cqmedical.com
• Phone: 800-842-8688
• Email: regulatory@cqmedical.com
• Phone: 800-842-8688
• Email: regulatory@cqmedical.com
• Phone: 800-842-8688
• Email: regulatory@cqmedical.com
• Phone: 800-842-8688
• Email: regulatory@cqmedical.com
• Phone: 800-842-8688
• Email: regulatory@cqmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841962119689 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171133

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: 2025-07-17
• Device Publish Date: 2025-07-09

On-Brand Devices [Stradivarius™]

• 10841962109717: Stradivarius SBRT Overlay
• 10841962109472: Stradivarius SBRT MRI Overlay
• 10841962109465: 48cm Variable Height Bridge for Stradivarius SBRT
• 10841962109458: 38cm Variable Height Bridge for Stradivarius SBRT
• 10841962109403: Stradivarius Compression Belt 150cm long Two belt sizes (115 cm / 150 cm)
• 00841962119689: Compression Paddle for Stradivarius SBRT System