kVue™ CT Overlay RT-4550KVTAQ2

GUDID 10841962110997

KVue CT Overlay for Canon Aquilion CT for 244cm long cradle

Qfix

Indexed-immobilization patient positioning system

• Primary Device ID: 10841962110997
• NIH Device Record Key: d4e1b9c6-8bea-4f8e-9581-f37e07f73393
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: kVue™ CT Overlay
• Version Model Number: RT-4550KVTAQ2
• Catalog Number: RT-4550KVTAQ2
• 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: 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com

Device Dimensions

• Length: 244 Centimeter
• Length: 244 Centimeter
• Length: 244 Centimeter
• Length: 244 Centimeter
• Length: 244 Centimeter
• Length: 244 Centimeter
• Length: 244 Centimeter
• Length: 244 Centimeter
• Length: 244 Centimeter
• Length: 244 Centimeter
• Length: 244 Centimeter
• Length: 244 Centimeter
• Length: 244 Centimeter
• Length: 244 Centimeter
• Length: 244 Centimeter
• Length: 244 Centimeter
• Length: 244 Centimeter
• Length: 244 Centimeter
• Length: 244 Centimeter
• Length: 244 Centimeter
• Length: 244 Centimeter
• Length: 244 Centimeter
• Length: 244 Centimeter
• Length: 244 Centimeter
• Length: 244 Centimeter
• Length: 244 Centimeter
• Length: 244 Centimeter
• Length: 244 Centimeter
• Length: 244 Centimeter
• Length: 244 Centimeter
• Length: 244 Centimeter
• Length: 244 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841962110997 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060671

FDA Product Code

• JAI: Couch, radiation therapy, powered

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: 2019-10-22
• Device Publish Date: 2019-10-14

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