Summit
Radiographic Image Receptor Stand
6manufacturers in China registered for this device type
8catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Beijing (2), Shanghai (2), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Siemens Shanghai, Medical Equipment Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Dongguan Wanjin Industrial Co., Ltd. | Dongguang | Guangdong | Remanufacturer | 41 |
| Jinyuan Medical Equipment(Tianjin)Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 27 |
| 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 | IXY |
| Device type | Holder, Radiographic Cassette, Wall-Mounted |
| Device class | Class 1 |
| Regulation | 21 CFR 892.1880 |
| Establishment | Complaint-file establishment, Manufacturer |
| Record published | 2016-11-01 |
| Record revised | 2021-04-29 (version 3) |
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 |
|---|---|---|
| S108 | In distribution | |
| S111 | In distribution | |
| S102 | In distribution | |
| J1000 | In distribution | |
| SST-3001-RS | In distribution | |
| A-172F | In distribution | |
| S107 | In distribution | |
| S109 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Varex Imaging | Varex Imaging Nederland B.V. | 38 |
| BR-120 | Shimadzu Corp. | 21 |
| BR-120T | Shimadzu Corp. | 19 |
| BR-120M | Shimadzu Corp. | 9 |
| Holder, Radiographic Cassette, Wall-Mounted | Ge Hualun Medical Systems Co., Ltd. | 8 |
| Del Medical, Inc. | DEL Medical, Inc. | 7 |
| Sedecal | Sedecal., Sa. | 6 |
| Kenex | Kenex (Electro-Medical) Ltd. | 5 |
| QW-420-T | Carestream Health, Inc. | 5 |
| Discovery RF180 | General Medical Merate SPA | 4 |
| Grid entity | Protec GmbH & Co. KG | 3 |
| Drgem | Drgem Corporation | 3 |
Showing 12 of 54. All products under Holder, Radiographic Cassette, Wall-Mounted
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K851440 | 1985-06-05 |
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.