Chronos Imaging LLC
10 catalogue numbers from AU200-C40+LMB, listed by Chronos Imaging, LLC, United States, 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 | Chronos Imaging, LLC, United States |
|---|---|
| FDA product code | ITY |
| Device type | Assembly, Tube Housing, X-Ray, Diagnostic |
| Device class | Class 1 |
| Regulation | 21 CFR 892.1760 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-12-29 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AU200-C40+LMB | In distribution | |
| DA165NP | In distribution | |
| S532Q | In distribution | |
| AU240 | In distribution | |
| CL200 0407 | In distribution | |
| AU200-C40 | In distribution | |
| S532B | In distribution | |
| AU200 | In distribution | |
| S532Q | In distribution | |
| DA135CTE | 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 |
| RTC 1000 HS | I.A.E. Industria Applicazioni Elettroniche SPA | 9 |
Showing 12 of 192. All products under Assembly, Tube Housing, X-Ray, Diagnostic
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2005-04-07 | Not classified | Other | The x-ray tube housing assembly may have been mounted with the incorrect sized bolts. | 37 units | 2005-10-20 |
| 2005-04-07 | Not classified | Other | The x-ray tube housing assembly may have been mounted with the incorrect sized bolts. | 69 units | 2005-10-20 |
| 2005-04-07 | Not classified | Other | The x-ray tube housing assembly may have been mounted with the incorrect sized bolts. | 4 units | 2005-10-20 |
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.