Roentgen Works

Roentgen Works 7.2.2 is a PACS, RIS, and Viewer.

Registry build 21.09.26
6manufacturers in China registered for this device type
71catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (2), Hebei (1), Guangxi (1).

Chinese manufacturers registered for FDA product code LMB
Manufacturer City Province Registered as Device types
Debo Medical Technology (Shijiazhuang) Co., Ltd. Shijiazhuang Hebei Contract manufacturer 117
Zogear Medical Co., Ltd. Yizheng Jiangsu Contract manufacturer 75
Wuxi Lyusmile IMP AND EXP Co., Ltd. Wuxi Jiangsu Private-label distributor 66
Guilin Yikeshi Medical Device Co Ltd Guilin Guangxi Manufacturer 28
Bgss Company Asia Limited Zhabei Shanghai Contract manufacturer 25
Dongguan Teac Electronics Co., Ltd. Dong Guan Guangdong Manufacturer 1

Record

Regulatory record for Roentgen Works
Listed by Brit Systems, United States
FDA product code LMB
Device type Device, Digital Image Storage, Radiological
Device class Class 1
Regulation 21 CFR 892.2010
Establishment Specification developer, Manufacturer
Record published 2020-04-24
Record revised 2023-12-04 (version 6)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information

Catalogue Numbers

Catalogue numbers for Roentgen Works
Catalogue number Size Status
3.9.2 In distribution
7.2.2 In distribution
6.1.0 In distribution
3.9.4 In distribution
6.3.1 In distribution
4.1.2 In distribution
7.1.1 In distribution
4.2.1 In distribution
5.1.3 In distribution
4.1.3 In distribution
5.5.3 In distribution
5.7.0 In distribution
5.6.0 In distribution
5.6.2 In distribution
3.9.1 In distribution
5.5.2 In distribution
7.2.0 In distribution
4.2.2 In distribution
5.0.4 In distribution
4.3.1 In distribution
5.6.1 In distribution
7.0.2 In distribution
5.1.0 In distribution
7.0.1 In distribution
4.3.2 In distribution
5.4.1 In distribution
5.0.0 In distribution
6.6.1 In distribution
3.8.4 In distribution
3.6.0 In distribution
6.0.1 In distribution
6.1.1 In distribution
5.0.5 In distribution
7.1.2 In distribution
7.1.0 In distribution
3.9.5 In distribution
3.9.3 In distribution
7.0.0 In distribution
7.2.1 In distribution
5.0.3 In distribution
5.1.2 In distribution
4.3.0 In distribution
4.1.0 In distribution
3.7.2 In distribution
6.2.0 In distribution
3.8.2 In distribution
6.3.0 In distribution
5.0.1 In distribution
6.6.2 In distribution
6.7.0 In distribution
3.9.0 In distribution
6.5.0 In distribution
4.2.3 In distribution
5.2.0 In distribution
5.2.1 In distribution
5.0.2 In distribution
5.5.0 In distribution
6.3.2 In distribution
6.0.0 In distribution
3.8.0 In distribution
5.3.0 In distribution
6.2.1 In distribution
6.6.0 In distribution
6.4.1 In distribution
4.2.0 In distribution
5.4.0 In distribution
4.1.1 In distribution
5.1.1 In distribution
4.0.0 In distribution
5.5.1 In distribution
6.4.0 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Evolution4K NDS Surgical Imaging, LLC. 40
UR-4MD Dongguan Teac Electronics Co., Ltd. 19
Vitegra® Joimax Gmbh 16
DMC-EZ Storage Solutions Technology Group Inc. 13
660HD-E Image Management System Smith & Nephew, Inc. 13
4Klearity NDS Surgical Imaging, LLC. 11
Hdmd PRO NDS Surgical Imaging, LLC. 8
UniRay Uniray Medical LLP 8
nCare Gyrus Acmi, Inc. 7
EvolutionHD NDS Surgical Imaging, LLC. 7
UR-NEXT4KH Teac Manufacturing Solutions Corporation 7
Viron R4K NDS Surgical Imaging, LLC. 5

Showing 12 of 44. All products under Device, Digital Image Storage, Radiological

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