XM1016 T
Catalogue number 0.1/0.3, listed by I.A.E. Industria Applicazioni Elettroniche SPA, under Assembly, Tube Housing, X-Ray, Diagnostic. 13 manufacturers in China are registered for this product code.
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.
| 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
| Listed by | I.A.E. Industria Applicazioni Elettroniche SPA |
|---|---|
| FDA product code | ITY |
| Device type | Assembly, Tube Housing, X-Ray, Diagnostic |
| Device class | Class 1 |
| Regulation | 21 CFR 892.1760 |
| Premarket notification | Exempt |
| Record published | 2020-08-25 |
| Record revised | 2025-11-17 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0.1/0.3 | In distribution |
Same 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 |
| Radii | Hangzhou Kailong Medical Instruments Co., Ltd. | 20 |
| 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 |
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.