Encompass™ RT-4600-14

GUDID 00841962119702

SRS E4 Headrest

Qfix

Head/neck procedure positioner

• Primary Device ID: 00841962119702
• NIH Device Record Key: cbdada63-66bd-42f9-b54c-5c189b711d15
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Encompass™
• Version Model Number: RT-4600-14
• Catalog Number: RT-4600-14
• 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	00841962119702 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152321

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 [Encompass™]

• 10841962110522: Encompass HexaPOD
• 10841962109502: kVue Encompass SRS Insert with E0 headrest & hand grip array
• 10841962109496: Encompass SRS MRI Standalone Device with E0 headrest & hand grip array
• 10841962109489: Encompass SRS Stand Alone Device with E0 headrest & hand grip array
• 00841962119719: SRS Cushion Support
• 00841962119702: SRS E4 Headrest
• 00841962119696: SRS E2 Headrest