Who else makes this device?

Name: 3D Brachy Application
Brand: 3D Brachy Application

Radiology › TherapeuticSystem, Planning, Radiation Therapy Treatment

3d Brachy Application

3D Brachy Software application is indicated for and intended for use as an accessory to a radiation therapy treatment planning system (TPS) to design patient-matched 3D printable…

Registry build 21.09.26

3D Brachy Software application is indicated for and intended for use as an accessory to a radiation therapy treatment planning system (TPS) to design patient-matched 3D printable accessories intended for use during surface brachytherapy. The use of 3D Brachy application is by prescription only.

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 3D Brachy Application
Listed by	Adaptiiv Medical Technologies, Inc., Canada
FDA product code	MUJ
Device type	System, Planning, Radiation Therapy Treatment
Device class	Class 2
Regulation	21 CFR 892.5050
Establishment	Manufacturer
Record published	2022-03-28

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for 3D Brachy Application
Catalogue number	Size	Status
v2021.1.0		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
K260308	2026-02-19
K243057	2024-10-23
K241318	2024-08-30
K213438	2022-01-19

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.