Prelude

The Prelude software supports radiation therapy workflows for IntraOp Mobetron, a radiation treatment device. It assists to find product specific machine parameters for treatment and can…

Registry build 21.09.26

The Prelude software supports radiation therapy workflows for IntraOp Mobetron, a radiation treatment device. It assists to find product specific machine parameters for treatment and can send those proposals to the console of the device. The machine parameters are not intended to be used for direct control for the radiation device.

5manufacturers in China registered for this device type
1catalogue number

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 Prelude
Listed by MedCom Gesellschaft für medizinische Bildverarbeitung mbH
FDA product code MUJ
Device type System, Planning, Radiation Therapy Treatment
Device class Class 2
Regulation 21 CFR 892.5050
510(k) K180308
Record published 2022-10-05

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries serial number

Catalogue Numbers

Catalogue numbers for Prelude
Catalogue number Size Status
V1. IORT In distribution

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

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