Summit
Radiographic Tubestand
5manufacturers in China registered for this device type
6catalogue numbers in this listing
1510(k) clearance
1recall
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 | Summit Industries, LLC, United States |
|---|---|
| FDA product code | IYB |
| Device type | Tube Mount, X-Ray, Diagnostic |
| Device class | Class 1 |
| Regulation | 21 CFR 892.1770 |
| Establishment | Complaint-file establishment, Manufacturer |
| Record published | 2016-11-07 |
| Record revised | 2021-08-09 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Storage | Handling environment atmospheric pressure 10 to 40 °C; Special storage condition: Keep dry |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| S225 | In distribution | |
| S105 | In distribution | |
| S203 | In distribution | |
| S114 | In distribution | |
| J700 | In distribution | |
| S113 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Drgem | Drgem Corporation | 12 |
| CH-200 | Shimadzu Corp. | 7 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K850198 | 1985-05-14 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2014-10-28 | Class II | Process control | The welds on J700 tube stands may be insufficient resulting in tube stand breakage, damage to the X-Ray machine, and/or patient or healthcare provider injury. | 32 | 2015-05-21 |
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.