MR-RT 781439

GUDID 00884838112780

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.

Radiation therapy treatment planning positioning kit

• Primary Device ID: 00884838112780
• NIH Device Record Key: abaa9053-9cf4-4e44-961c-c77bbe023f79
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MR-RT
• Version Model Number: RT CouchTop XD
• Catalog Number: 781439
• Company DUNS: 413819707
• Company Name: Philips Medical Systems Nederland B.V.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 1 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838112780 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K214081

FDA Product Code

• LNH: System, Nuclear Magnetic Resonance Imaging

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-09
• Device Publish Date: 2022-09-01

On-Brand Devices [MR-RT]

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