Insight™ RT-4700-04

GUDID 10841962119389

Insight™ MR Overlay Head and Shoulders, Siemens Free.Max

Qfix

Radiation therapy treatment planning positioning kit

• Primary Device ID: 10841962119389
• NIH Device Record Key: d43f6bdf-0692-473b-b6a8-a9aa50337b36
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Insight™
• Version Model Number: RT-4700-04
• Catalog Number: RT-4700-04
• Company DUNS: 808875397
• Company Name: Qfix
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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(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 Identifiers

Device Issuing Agency	Device ID
GS1	10841962119389 [Primary]

FDA Product Code

• KXJ: Table, radiologic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-12-11
• Device Publish Date: 2023-01-24

On-Brand Devices [Insight™]

• 10841962109953: Insight™ MRI Bridge with Body Coil Holder
• 10841962119396: Insight™ MR Head Coil Holder, Siemens Free.Max
• 10841962119389: Insight™ MR Overlay Head and Shoulders, Siemens Free.Max
• 10841962109946: Insight™ MR Head Coil Holder
• 10841962109939: Insight™ MR Overlay