Gendex GXS-700™ Intraoral Sensor
Size 1, Size 2
10manufacturers in China registered for this device type
19catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (3), Guangdong (2), Shanghai (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| iRay Imaging Technology Taicang Limited | Taicang | Jiangsu | Contract manufacturer | 3 |
| Guilin Woodpecker Medical Instrument Co., Ltd. | Guilin | Guangxi | Manufacturer | 25 |
| Changzhou Sifary Medical Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 14 |
| Jiangsu Dynamic Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 12 |
| Orich Medical Equipment (Tianjin) Co., Ltd. | Tianjin | Tianjin | Manufacturer | 5 |
| Ningbo Runyes Medical Instrument Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 4 |
| Shenzhen Xpectvision Technology Co., Ltd. | Shenzhen | Guangdong | Repacker / relabeller | 4 |
| iRay Group | Shanghai | Shanghai | Specification developer | 4 |
| Fussen Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 3 |
| Shanghai Handy Medical Equipment Co., Ltd. | Shanghai | Shanghai | Manufacturer | 2 |
Record
| Listed by | Gendex Corp., United States |
|---|---|
| FDA product code | MUH |
| Device type | System, X-Ray, Extraoral Source, Digital |
| Device class | Class 2 |
| Regulation | 21 CFR 872.1800 |
| 510(k) | K090458 |
| Record published | 2016-09-24 |
| Record revised | 2022-01-31 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment temperature 5 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1.007.6202 | In distribution | |
| 1.010.7656 | In distribution | |
| 1.007.6200 | In distribution | |
| 1.007.6201 | In distribution | |
| 1.008.5054 | In distribution | |
| 0.822.4598 | In distribution | |
| 1.010.8119 | In distribution | |
| 0.822.5013 | In distribution | |
| 1.008.5052 | In distribution | |
| 1.010.7863 | In distribution | |
| 0.822.5011 | In distribution | |
| 1.010.7864 | In distribution | |
| 0.822.5012 | In distribution | |
| 1.008.5053 | In distribution | |
| 1.008.5055 | In distribution | |
| 0.822.4599 | In distribution | |
| 1.010.8118 | In distribution | |
| 1.010.7655 | In distribution | |
| 1.010.7654 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Schick Elite | Sirona Dental, Inc. | 38 |
| Schick Wifi | Sirona Dental, Inc. | 31 |
| Midmark Intraoral Digital Sensor | Midmark Corporation | 26 |
| Xios XG Wifi | Sirona Dental, Inc. | 25 |
| Midmark OptiMax Digital Sensor System | Midmark Corporation | 24 |
| Genoray | Genoray Co., Ltd. | 14 |
| X-Mind trium | DE Götzen SRL | 12 |
| X-Mind optima 3D | DE Götzen SRL | 12 |
| Dexis Titanium Sensor Kit | Dental Imaging Technologies Corporation | 11 |
| Xios XG Select | Sirona Dental, Inc. | 11 |
| Planmeca ProMax | Planmeca Oy | 11 |
| CDR Elite | Sirona Dental, Inc. | 11 |
Showing 12 of 279. All products under System, X-Ray, Extraoral Source, Digital
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.