MR-RT CouchTop

Basic Information

• Brand Name: MR-RT CouchTop
• Primary DI: 00884838068490
• Version / Model: 459800573512
• Company Name: Philips Oy
• Labeler DUNS: 539852079
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 5
• Public Version Date: 2023-01-23
• Public Version Status: Update
• Public Device Record Key: 2d69647c-2742-43d6-935c-9da319cc50c2
• Distribution End Date: 2022-10-01

Device Description

MR-RT is an add-on to the existing Ingenia 1.5T and 3.0T MR systems that makes the system suitable for MR imaging for radiation therapy planning purposes.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
LNH	System, nuclear magnetic resonance imaging	Radiology	892.1000	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37654	Full-body MRI system, superconducting magnet	A diagnostic general-purpose magnetic resonance imaging (MRI) system designed to scan any targeted area of the body (full-body imaging). This system includes a superconducting magnet assembly and can be fixed-location, mobile, or transportable. Some systems can perform MR spectroscopy or various real-time imaging procedures for MRI guided interventional, therapeutic, or surgical applications. The system is available in a variety of system gantry configurations including closed bore, open bore, and open-sided or other kinds of patient accessible designs.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00884838068490	GS1

Customer Contacts

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