Best TPS

The Best TPS system is a computer based software system developed the use of assisting in the placement of anatomical localization and low dose rate isotope implants Best TPS uses multiple…

Registry build 21.09.26

The Best TPS system is a computer based software system developed the use of assisting in the placement of anatomical localization and low dose rate isotope implants Best TPS uses multiple two-dimensional images including ultrasound and DICOM images which are outlined by a qualified medical staff member, then reconstructed to create three dimensional structures and matrices.

5manufacturers in China registered for this device type
1catalogue number
4510(k) clearances naming this product code

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 Best TPS
Listed by Best Nomos, United States
FDA product code MUJ
Device type System, Planning, Radiation Therapy Treatment
Device class Class 2
Regulation 21 CFR 892.5050
Establishment Complaint-file establishment, Manufacturer
510(k) K981678
Record published 2016-10-31
Record revised 2018-07-06 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Best TPS
Catalogue number Size Status
209867 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

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K211034 2021-05-06
K201350 2020-09-20
K151469 2015-11-25
K100092 2010-02-23

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