MR-RT

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…

Registry build 21.09.26

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)

5manufacturers in China registered for this device type
4catalogue numbers in this listing
1510(k) clearance

Who Else Makes It

Concentrated in Jiangsu (2), Fujian (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code MUJ
Manufacturer City Province Registered as Device types
Philips Healthcare (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 5
Manteia Technologies Co., Ltd. Xiamen Fujian Manufacturer 3
Masep Medical Science & Technology DEVELOPMENT(SHENZHEN)Co. Shenzhen Guangdong Manufacturer 2
Suzhou Linatech Medical Science AND Technology Co., Ltd. Suzhou Jiangsu Manufacturer 2
Varian Medical Systems China Co., Ltd. Beijing Beijing Manufacturer 2

Record

Regulatory record for MR-RT
Listed by Philips Healthcare Group, United States
FDA product code MUJ
Device type System, Planning, Radiation Therapy Treatment
Device class Class 2
Regulation 21 CFR 892.5050
Record published 2022-04-26
Record revised 2025-12-15 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries lot or batch number, serial number
Storage Storage environment humidity 20 to 95 % RH
Distribution end date 2022-10-01

Catalogue Numbers

Catalogue numbers for MR-RT
Catalogue number Size Status
MRCAT Brain / RTgo 4.1 In distribution
MRCAT Brain / RTgo 4.0 In distribution
RTgo 5.0 Withdrawn
RT CouchTop XD Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
RayStation RaySearch Laboratories AB (publ) 29
System, Planning, Radiation Therapy Treatment Nucletron B.V. 17
Panther TPS Prowess, Inc. 14
RayCare RaySearch Laboratories AB (publ) 12
Accuray Precision® Treatment Planning System Accuray Incorporated 7
Monaco Elekta Inc. 7
Eclipse Treatment Planning System for External Beam Radiation Therapy Varian Medical Systems, Inc 6
syngo.via RT Image Suite Siemens Healthcare Limited 5
Eclipse Treatment Planning System Varian Medical Systems, Inc 5
Corvus 09 Best Nomos 4
Monaco Elekta Solutions AB 4
XKnife® Integra Lifesciences Corporation 4

Showing 12 of 98. All products under System, Planning, Radiation Therapy Treatment

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K214081 2022-04-05

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer