X-Mind Unity
The X-MIND unity is an X-ray generator for dental intra-oral x-ray imaging, particularly, the X-MIND unity is an extra-oral source of X-rays, intended to be used for producing diagnostic…
The X-MIND unity is an X-ray generator for dental intra-oral x-ray imaging, particularly, the X-MIND unity is an extra-oral source of X-rays, intended to be used for producing diagnostic dental radiographs for treatment of disease of the teeth, jaw and oral structures. This version includes wall plate
8manufacturers in China registered for this device type
26catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangxi (2), Guangdong (2), Zhejiang (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guilin Woodpecker Medical Instrument Co., Ltd. | Guilin | Guangxi | Manufacturer | 25 |
| Changzhou Sifary Medical Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 14 |
| Guangzhou Ajax Medical Equipment Co Ltd | Guangzhou | Guangdong | Manufacturer | 13 |
| Guilin Refine Medical Instrument Co., Ltd. | Guilin | Guangxi | Contract manufacturer | 7 |
| iRay Imaging Technology (Haining) Limited | Haining | Zhejiang | Contract manufacturer | 6 |
| 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 |
Record
| Listed by | DE Götzen SRL |
|---|---|
| FDA product code | EHD |
| Device type | Unit, X-Ray, Extraoral With Timer |
| Device class | Class 2 |
| Regulation | 21 CFR 872.1800 |
| 510(k) | K132378 |
| Record published | 2016-09-01 |
| Record revised | 2023-06-12 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature 0 to 50 °C; Storage environment humidity 25 to 75 % RH; Storage environment atmospheric pressure 85 to 106 KiloPascal; Handling environment temperature 10 to 40 °C; Handling environment humidity 25 to 75 % RH; Handling environment atmospheric pressure 85 to 106 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| XMU TOP 40 LONG SQUARE CONE | In distribution | |
| XMU BOTTOM 80 LONG CONE | In distribution | |
| XMU TOP 110 LONG CONE | In distribution | |
| XMU BOTTOM 40 LONG SQUARE CONE | In distribution | |
| XMU TOP 40 LONG CONE | In distribution | |
| XMU TOP 80 SHORT CONE | In distribution | |
| XMU TOP 110 SHORT CONE, INTERF WALL PLATE (16” – 40,64cm) | In distribution | |
| XMU TOP 80 LONG SQUARE CONE | In distribution | |
| XMU TOP 80 SHORT CONE, INTERF WALL PLATE (16” – 40,64cm) | In distribution | |
| XMU TOP 40 SHORT CONE | In distribution | |
| XMU CORE KIT VET SC NO BRACKET | In distribution | |
| XMU BOTTOM 80 LONG SQUARE CON | In distribution | |
| XMU TOP 110 LONG SQUARE CONE | In distribution | |
| XMU BOTTOM 110 LONG CONE | In distribution | |
| XMU BOTTOM 40 LONG CONE | In distribution | |
| XMU TOP 80 LONG CONE | In distribution | |
| XMU TOP 110 SHORT CONE | In distribution | |
| XMU BOTTOM 80 SHORT CONE | In distribution | |
| XMU TOP 40 SHORT CONE, INTERF WALL PLATE (16” – 40,64cm) | In distribution | |
| XMU NO BRACKET LONG CONE | In distribution | |
| XMU BOTTOM 40 SHORT CONE | In distribution | |
| XMU BOTTOM 110 SHORT CONE | In distribution | |
| XMU BOTTOM 110 LONG SQUARE CONE | In distribution | |
| XMU NO BRACKET SHORT CONE | In distribution | |
| XMU TIMER STD | In distribution | |
| XMU CORE KIT SC NO BRACK NO TIMER | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Midmark | Midmark Corporation | 148 |
| Midmark Preva IntraOral Dental X-ray System | Midmark Corporation | 136 |
| Schick AE | Sirona Dental, Inc. | 53 |
| Midmark Preva 2.0 IntraOral Dental X-ray System | Midmark Corporation | 46 |
| Xios AE | Sirona Dental, Inc. | 38 |
| Midmark Vetpro IntraOral Dental X-ray System | Midmark Corporation | 26 |
| x-mind dc | DE Götzen SRL | 17 |
| Owandy-RX DC | Owandy Radiology | 16 |
| Orthophos XG | Sirona Dental Systems Gmbh | 10 |
| Schick Elite | Sirona Dental, Inc. | 10 |
| Phot-X IIs Model 505 | Takara Belmont Corporation | 10 |
| CDR Elite | Sirona Dental, Inc. | 10 |
Showing 12 of 171. All products under Unit, X-Ray, Extraoral With Timer
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.