AccessGUDID - DEVICE: MR 5000 Series (00884838112841)

GUDID

Device Identifier (DI) Information

Brand Name: MR 5000 Series
Version or Model: MR 5300
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 782152
Company Name: Philips Medical Systems Nederland B.V.

Primary DI Number: 00884838112841
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 413819707 *Terms of Use

Device Description: Philips innovative MR 5300 magnetic resonance imaging system simplifies and automates the most complex clinical and operational tasks. So you can create highly personalized exams of even your most challenging patients. Quickly. Easily. Intelligently. Smart Workflow reduces the number of steps needed to complete an MR exam and enables guided patient set-up in under a minute, the ultra-lightweight and flexible Breeze coils help cut patient change-over time by 30% to keep your MR department on schedule. At the same time, they improve patient comfort and staff satisfaction. This will help you meeting the challenging demands of productivity and patient throughput at private clinics and diagnostic imaging centers. MR 5300 is not only a fast MR, but also smart and flexible, providing intelligent tools for fast exams and quality scanning.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LNH	System, Nuclear Magnetic Resonance Imaging

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K223442	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Humidity: between 20 and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Temperature: between -20 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9ee0e7b1-41e5-4949-975b-0883a2ceb0b5
Public Version Date: September 26, 2023
Public Version Number: 2
DI Record Publish Date: May 09, 2023