Generator, High-Voltage, X-Ray, Diagnostic
LINE POWER RATING: 400V3~, 50/60Hz OUTPUT RATING: 82kW(1000mA@82kV, 800mA@102kV, 500mA@150kV) KVP range: 40~150kVp mA range: 10~1000mA mAs Range: 0.1~500mAs
6manufacturers in China registered for this device type
5catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (3), Anhui (1), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Siemens X-RAY Vacuum Technology Ltd. | Wuxi | Jiangsu | Contract manufacturer | 2 |
| Hefei MT Medical Co., Ltd. | Hefei | Anhui | Manufacturer | 23 |
| Carestream Health, Inc., Global R&D Center | Shanghai | Shanghai | Specification developer | 8 |
| iRay Imaging Technology (Haining) Limited | Haining | Zhejiang | Contract manufacturer | 6 |
| Suzhou Powersite Electric Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 2 |
| Spellman High Voltage Electronics(Suzhou Industrial Park)Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 2 |
Record
| Listed by | Ecotron Co., Ltd., South Korea |
|---|---|
| FDA product code | IZO |
| Device type | Generator, High-Voltage, X-Ray, Diagnostic |
| Device class | Class 1 |
| Regulation | 21 CFR 892.1700 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-10-27 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Storage | Storage environment humidity 5 to 95 % RH; Storage environment temperature -10 to 70 °C; Handling environment humidity 30 to 75 % RH; Handling environment temperature 10 to 40 °C |
| Sizes | Height 640 mm; width 430 mm; length 620 mm; weight 80 kg |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SXG-80R | Height 640 mm | In distribution |
| SXG-52R | Height 640 mm | In distribution |
| SXG-40R | Height 640 mm | In distribution |
| SXG-68R | Height 640 mm | In distribution |
| SXG-32R | Height 640 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Varex Imaging | Varex Imaging Corporation | 102 |
| Sedecal | Sedecal., Sa. | 88 |
| Varex Imaging | Varex Imaging Nederland B.V. | 61 |
| Editor HFe | Spellman High Voltage Electronics Corp. | 53 |
| Drgem | Drgem Corporation | 48 |
| S Spellman High Voltage Electronics Corporation | Spellman High Voltage Electronics(Suzhou Industrial Park)Co., Ltd. | 36 |
| iRay | iRay Imaging Technology (Haining) Limited | 25 |
| Delta | Delta Electronics, Inc. Chungli 5 Plant | 22 |
| CMP 200 DR | Communications & Power Industries Canada, Inc. | 17 |
| Indico IQ | Communications & Power Industries Canada, Inc. | 12 |
| Epsilon High Voltage Generator | EMD Technologies Incorporated | 11 |
| UD150B-40 | Shimadzu Corp. | 7 |
Showing 12 of 49. All products under Generator, High-Voltage, X-Ray, Diagnostic
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.