AccessGUDID - DEVICE: MR-RT (00884838107311)

GUDID

Device Identifier (DI) Information

Brand Name: MR-RT
Version or Model: RTgo 5.0 5
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 300005806302
Company Name: Philips Oy

Primary DI Number: 00884838107311
Issuing Agency: GS1
Commercial Distribution End Date: September 01, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 539852079 *Terms of Use

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. MR-RT consists of RTGo SW and MR CouchTop accessory. RTgo is a software that provides MR-RT functionality including MRCAT (MRCAT Prostate, MRCAT Pelvis, MRCAT Brain, MRCAT Head &Neck)

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?
40872	MRI system application software	An individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a magnetic resonance imaging (MRI) system configuration. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software programs or program packages must be combined with specific hardware or firmware configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MUJ	System, planning, radiation therapy treatment

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K214081	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bce14942-3a04-4d2d-9eb4-2bcd24f1c73d
Public Version Date: January 23, 2023
Public Version Number: 2
DI Record Publish Date: June 14, 2022