Portrait Head & Neck Mask Adapter for Access Supine RT-4546-04

GUDID 00841962120418

Portrait Head & Neck Mask Adapter for Access Supine

Qfix

Radiological breast positioner, non-wearable

• Primary Device ID: 00841962120418
• NIH Device Record Key: ae73eff6-1fd4-49b3-89fd-578c9680096d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Portrait Head & Neck Mask Adapter for Access Supine
• Version Model Number: RT-4546-04
• Catalog Number: RT-4546-04
• Company DUNS: 808875397
• Company Name: Qfix
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: +1 712-737-8688
• Email: regulatory@cqmedical.com
• Phone: +1 712-737-8688
• Email: regulatory@cqmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841962120418 [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: 2025-12-10
• Device Publish Date: 2025-12-02

Devices Manufactured by Qfix

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• 00841962120395 - Symphony Locating Bar, PH Style: 2025-12-10 Symphony Locating Bar, PH Style
• 00841962120401 - Portrait Head Only Mask Adapter for Access Supine: 2025-12-10 Portrait Head Only Mask Adapter for Access Supine
• 00841962120418 - Portrait Head & Neck Mask Adapter for Access Supine: 2025-12-10Portrait Head & Neck Mask Adapter for Access Supine
• 00841962120418 - Portrait Head & Neck Mask Adapter for Access Supine: 2025-12-10 Portrait Head & Neck Mask Adapter for Access Supine
• 10841962119464 - Symphony Locating Bar, PH Style: 2025-12-03 Symphony Locating Bar, PH Style
• 00841962119856 - IntegraBite: 2025-11-21 IntegraBite Plates
• 00841962120340 - Edge Guide System: 2025-09-19 Lithotomy Edge Guide System
• 00841962119467 - Alpine Stirrups: 2025-07-17 Stirrup, Left