MR-RT 300005806302

GUDID 00884838107311

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 softwar

Philips Oy

MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software

• Primary Device ID: 00884838107311
• NIH Device Record Key: bce14942-3a04-4d2d-9eb4-2bcd24f1c73d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MR-RT
• Version Model Number: RTgo 5.0 5
• Catalog Number: 300005806302
• Company DUNS: 539852079
• Company Name: Philips Oy
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838107311 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K214081

FDA Product Code

• MUJ: System, planning, radiation therapy treatment

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: 2022-06-22
• Device Publish Date: 2022-06-14

On-Brand Devices [MR-RT]

• 00884838098206: MR-RT is an add-on to the existing Ingenia 1.5T and 3.0T MR systems that makes the system suitab
• 00884838094093: MR-RT is an add-on to the existing Ingenia 1.5T and 3.0T MR systems that makes the system suitab
• 00884838107311: MR-RT is an add-on to the existing Ingenia 1.5T and 3.0T MR systems that makes the system suitab
• 00884838103528: MR-RT is an add-on to the existing Ingenia 1.5T and 3.0T MR systems that makes the system suitab