CH-200
7 catalogue numbers from 503-58100-27, listed by Shimadzu Corp., United States, under Tube Mount, X-Ray, Diagnostic. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
7catalogue numbers in this listing
Who Else Makes It
Concentrated in Beijing (2), Jiangsu (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Dongguan Wanjin Industrial Co., Ltd. | Dongguang | Guangdong | Remanufacturer | 41 |
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Carestream Health, Inc., Global R&D Center | Shanghai | Shanghai | Specification developer | 8 |
Record
| Listed by | Shimadzu Corp., United States |
|---|---|
| FDA product code | IYB |
| Device type | Tube Mount, X-Ray, Diagnostic |
| Device class | Class 1 |
| Regulation | 21 CFR 892.1770 |
| Premarket notification | Exempt |
| Record published | 2016-12-21 |
| Record revised | 2025-05-28 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 503-58100-27 | In distribution | |
| 503-58100-34 | In distribution | |
| 503-58100-26 | In distribution | |
| 563-58100-96 | In distribution | |
| 563-58100-95 | In distribution | |
| 563-58100-76 | In distribution | |
| 503-58100-28 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Drgem | Drgem Corporation | 12 |
| Summit | Summit Industries, LLC | 6 |
| CH-200M | Shimadzu Corp. | 6 |
| Sedecal | Sedecal., Sa. | 6 |
| Del Medical, Inc. | DEL Medical, Inc. | 6 |
| Tube Mount, X-Ray, Diagnostic | Ge Hualun Medical Systems Co., Ltd. | 4 |
| QS-500 | Carestream Health, Inc. | 4 |
| FH-21HR | Shimadzu Corp. | 4 |
| Paxis 100 Auto | Pausch, L.L.C. | 3 |
| FH-20HR | Shimadzu Corp. | 3 |
| SS-2100 | Shinyoung FOR M Co., Ltd. | 2 |
| Universal | DEL Medical, Inc. | 2 |
Showing 12 of 38. All products under Tube Mount, X-Ray, Diagnostic
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Shimadzu Corporation Medical Systems Division | UDI-DI | 2025-10-16 | Class II | Device Design | Due to an issue (potential breakage) with the shaft for the mounting of the X-ray tube assembly that could potentially result assembly coming off the rotating shaft. | 1,766 devices |
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.