Who else makes this device?

Name: .decimal Proton Shell and Lid Assembly
Brand: .decimal Proton Shell and Lid Assembly

Radiology › TherapeuticSystem, Planning, Radiation Therapy Treatment

.decimal Proton Shell and Lid Assembly

A reusable steel Shell & Lid (or material with similar attenuating properties) with a 2D hole cut from it which is where the custom Brass core is to be placed for treatment with a proton…

Registry build 21.09.26

A reusable steel Shell & Lid (or material with similar attenuating properties) with a 2D hole cut from it which is where the custom Brass core is to be placed for treatment with a proton beam.

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 Proton Shell and Lid Assembly
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)	K132236
Record published	2016-09-24
Record revised	2018-07-06 (version 3)

Specifications

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

Catalogue Numbers

Catalogue numbers for.decimal Proton Shell and Lid Assembly
Catalogue number	Size	Status
2.3		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.