Insight™

Basic Information

• Brand Name: Insight™
• Primary DI: 10841962109939
• Version / Model: RT-4700-01
• Catalog Number: RT-4700-01
• Company Name: Qfix
• Labeler DUNS: 808875397
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-13
• Public Version: 3
• Public Version Date: 2023-12-11
• Public Version Status: Update
• Public Device Record Key: f38008f7-9011-4635-96d0-b6261b3c6a81

Device Description

Insight™ MR Overlay

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KXJ	Table, radiologic	Radiology	892.1980	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61110	Radiation therapy treatment planning positioning kit	A collection of non-sterile devices intended to assist collection of diagnostic magnetic resonance imaging (MRI) images to be used as part of radiation therapy treatment planning. It includes multiple devices intended to ensure adequate positioning and/or immobilization of the patient during MRI imaging (e.g., radiological whole-body positioning frame/board, laser patient positioning system), and may include imaging supportive/reference devices (e.g., MRI phantom).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10841962109939	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]