Geometric QA Phantom

Basic Information

• Brand Name: Geometric QA Phantom
• Primary DI: 00884838068506
• Version / Model: 459800438932
• Company Name: Philips Oy
• Labeler DUNS: 539852079
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 2a6fc827-a460-47f2-ad39-a6a8f3998484

Device Description

The Geometric Quality Assurance Phantom is intended to provide the operator with spatial reference information that can aid the operator to assess whether or not the amount of geometric distortions of the MR scanner is acceptable for the intended application.

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: Yes
• PM Exempt: Yes
• 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
LHO	Instrument, quality-assurance, radiologic	Radiology	892.1940	1

GMDN Terms

Code	Name	Definition	Implantable	Status
40636	MRI phantom, test object	A device that consists of a uniform density, or a two or three-dimensional (3-D) pattern of objects, materials or openings of varying dimensions and material densities. It is available in both fixed and variable configurations and is a quality assurance (QA) device used in both subjective and quantitative evaluations of various calibration and performance characteristics of magnetic resonance imaging (MRI) systems or magnetic resonance spectroscopy systems and associated image acquisition, display, and analysis computer programs.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00884838068506	GS1

Customer Contacts

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