Universal
An x-ray system component intended to be mounted to the floor and wall or floor and ceiling, to support and facilitate position of the x-ray tube.
5manufacturers in China registered for this device type
2catalogue numbers in this listing
3recalls on this code
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 | DEL Medical, Inc., United States |
|---|---|
| FDA product code | IYB |
| Device type | Tube Mount, X-Ray, Diagnostic |
| Device class | Class 1 |
| Regulation | 21 CFR 892.1770 |
| Establishment | Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-04-15 |
| Record revised | 2026-03-06 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FWFC (non-rotate) | In distribution | |
| FWFC (rotate) | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Drgem | Drgem Corporation | 12 |
| CH-200 | Shimadzu Corp. | 7 |
| 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 |
Showing 12 of 38. All products under Tube Mount, 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 |
|---|---|---|---|---|---|
| 2009-01-12 | Not classified | Component design/selection | There is the potential for the supporting cable to become detached from the column causing the column to fall and possibly contact the patient or operator. | 213 devices | 2010-06-17 |
| 2005-03-10 | Not classified | Other | The Phantom Portable X-Ray System Stand may have a suspect weld supporting the bracket holding the locking cylinder assembly. It the weld fails, the tubehead arm assembly could fall and contact the patient or operator. | 31 stands | 2005-11-14 |
| 2004-02-13 | Not classified | Other | There is a potentially defective worm gear in the tension adjusting mechanism of the balancer used in the Digital Ceiling Mounted Tube Support System for overhead x-ray units. | 57 units | 2004-09-30 |
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.