.decimal P.D

The p.d software helps radiation therapy professionals design and measure devices that shape or modify treatment beams. It receives information from treatment planning systems and converts…

Registry build 21.09.26

The p.d software helps radiation therapy professionals design and measure devices that shape or modify treatment beams. It receives information from treatment planning systems and converts filter designs into files that can be sent for manufacture. It supports devices for photon, electron and particle radiotherapy.

The software can also create beam shaping or compensating filter designs from planning data and other user supplied information. Designs return to a commissioned treatment planning system for final dose verification before the physical devices are ordered and used to treat a patient.

Listed Item

p.d software aid’s radiation therapy professionals in the design, construction, and testing of radiotherapy beam modifying devices.

Quality Assurance Tools

Tools analyze scanned images, including CT images, to measure and test the physical characteristics of radiotherapy devices. A simplified dose calculator supports design changes within p.d, while final dose verification remains part of the treatment planning workflow.

5manufacturers in China registered for this device type
1catalogue number
7510(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.decimal P.D
Listed by .Decimal, Inc., United States
FDA product code MUJ
Device type System, Planning, Radiation Therapy Treatment
Device class Class 2
Regulation 21 CFR 892.5050
510(k) K151369
Record published 2016-09-24
Record revised 2018-07-06 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Label carries serial number

Catalogue Numbers

Catalogue numbers for.decimal P.D
Catalogue number Size Status
5.1 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
K211511 2021-07-01
K192554 2019-12-13
K173940 2018-05-15
K151369 2015-08-07
K150547 2015-05-15
K083672 2009-04-13
K061440 2006-06-27

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