Radii

X-ray tube assembly is intended to be used as integrated part of compatible medical diagnostic X-ray equipment, for generating X-rays.

Registry build 21.09.26
13manufacturers in China registered for this device type
20catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (7), Beijing (3), Guangdong (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code ITY
Manufacturer City Province Registered as Device types
Siemens X-RAY Vacuum Technology Ltd. Wuxi Jiangsu Contract manufacturer 2
Varex Imaging Equipment (China) Co., Ltd. Wuxi Jiangsu Contract manufacturer 1
GE Hangwei Medical Systems Co., Ltd. Beijing Beijing Specification developer 22
GE Healthcare (China) Co., Ltd. Beijing Beijing Specification developer 22
Wuxi Yushou Medical Appliances Co., Ltd. Wuxi Jiangsu Contract manufacturer 8
Spellman High Voltage Electronics(Suzhou Industrial Park)Co., Ltd. Suzhou Jiangsu Manufacturer 2
Beijing Smartbeam Medical Devices Co., Ltd. Beijing Beijing Contract manufacturer 1
Hangzhou Kailong Medical Instruments Co., Ltd. Hangzhou Zhejiang Manufacturer 1
Konason (Guangdong) Medical Imaging Technology Co., Ltd. Dongguan Guangdong Manufacturer 1
Mingwei Medical Technology(Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 1
Micro X-ray Technology (Suzhou) Co., Ltd. Suzhou Jiangsu Manufacturer 1
Wuxi Guochen Medical Technology Co., Ltd. Wuxi Jiangsu Manufacturer 1

Showing 12 of 13. All 13 manufacturers in China registered for Assembly, Tube Housing, X-Ray, Diagnostic

Record

Regulatory record for Radii
Listed by Hangzhou Kailong Medical Instruments Co., Ltd., China
FDA product code ITY
Device type Assembly, Tube Housing, X-Ray, Diagnostic
Device class Class 1
Regulation 21 CFR 892.1760
Establishment Manufacturer
Premarket notification Exempt
Record published 2018-04-18
Record revised 2025-08-13 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Latex Contains natural rubber latex
Label carries manufacturing date, serial number
Distribution end date 2020-12-31

Catalogue Numbers

Catalogue numbers for Radii
Catalogue number Size Status
H1076X In distribution
H5077T In distribution
H1076X In distribution
H1080Y In distribution
H1076X In distribution
H1080Y In distribution
H2100 Withdrawn
H1074X Withdrawn
H2090 Withdrawn
H2106 Withdrawn
H1076 Withdrawn
H2103 Withdrawn
H1086 Withdrawn
H2092 Withdrawn
H1075 Withdrawn
H1080 Withdrawn
H1083 Withdrawn
H2108X Withdrawn
H2107 Withdrawn
H1077 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Rotating Anode X-ray Tube Assembly Canon Electron Tubes & Devices Co., Ltd. 76
Dunlee Dunlee 67
Mingwei Mingwei Medical Technology(Suzhou) Co., Ltd. 52
Medical CT X-Ray Tube Wuxi Guochen Medical Technology Co., Ltd. 27
Smartbeam Beijing Smartbeam Technology Co., Ltd. 27
Medical CT X-Ray Tube Assembly Wuxi Guochen Medical Technology Co., Ltd. 27
CTR2150 Philips Medical Systems DMC GmbH 15
Medical CT X-ray tube assembly Beijing Smartbeam Medical Devices Co., Ltd. 14
Medical diagnostic rotating anode X-ray tube Beijing Smartbeam Medical Devices Co., Ltd. 13
CTR2280 Philips Medical Systems DMC GmbH 10
Chronos Imaging LLC Chronos Imaging, LLC 10
RTC 1000 HS I.A.E. Industria Applicazioni Elettroniche SPA 9

Showing 12 of 192. All products under Assembly, Tube Housing, X-Ray, Diagnostic

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