MR-RT 781439

GUDID 00884838112759

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)

Philips Medical Systems Nederland B.V.

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Primary Device ID00884838112759
NIH Device Record Key05dac65f-db4e-490a-97af-5efdaf3dfb2d
Commercial Distribution StatusIn Commercial Distribution
Brand NameMR-RT
Version Model NumberMR-RT CouchTop
Catalog Number781439
Company DUNS413819707
Company NamePhilips Medical Systems Nederland B.V.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 1 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 1 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 1 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 1 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 1 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 1 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 1 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 1 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 1 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 1 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 1 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 1 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 1 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 1 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 1 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 1 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 1 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 1 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 1 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 1 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 1 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 1 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 1 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 1 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 1 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 1 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 1 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 1 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 1 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 1 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 1 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 1 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 1 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100884838112759 [Primary]

FDA Product Code

LNHSystem, Nuclear Magnetic Resonance Imaging

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-09
Device Publish Date2022-09-01

On-Brand Devices [MR-RT]

00884838112780MR-RT is an add-on to the existing Ingenia 1.5T and 3.0T MR systems that makes the system suitab
00884838112759MR-RT is an add-on to the existing Ingenia 1.5T and 3.0T MR systems that makes the system suitab
00884838112742MR-RT is an add-on to the existing Ingenia 1.5T and 3.0T MR systems that makes the system suitab
00884838122123MR-RT is an add-on to the existing Ingenia 1.5T and 3.0T MR systems that makes the system suitab

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