X-Mind Optima 3d
X-MIND optima 3D, PAN/CBCT/CEPH DRT configuration, floor mounted version, without workstation and monitor
10manufacturers in China registered for this device type
12catalogue 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 | DE Götzen SRL |
|---|---|
| FDA product code | MUH |
| Device type | System, X-Ray, Extraoral Source, Digital |
| Device class | Class 2 |
| Regulation | 21 CFR 872.1800 |
| 510(k) | K201382 |
| Record published | 2024-07-30 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -20 to 70 °C; Storage environment humidity 0 to 95 % RH; Storage environment atmospheric pressure 63 to 106 KiloPascal; Handling environment temperature 10 to 35 °C; Handling environment humidity 30 to 75 % RH; Handling environment atmospheric pressure 70 to 106 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| XMO 3D FLOOR 100-240V NO WS NO MONITOR | In distribution | |
| XMO 3D CEPH 100-240V NO WS NO MONITOR | In distribution | |
| XMO 3D FLOOR 100-240V 1210 NO WS NO MONITOR | In distribution | |
| XMO 3D CEPH 100-240V 1210 NO WS NO MONITOR | In distribution | |
| XMO 3D CEPH 100-240V + WS + MONITOR | In distribution | |
| XMO 3D WALL 100-240V NO WS NO MONITOR | In distribution | |
| XMO 3D WALL 100-240V + WS + MONITOR | In distribution | |
| XMO 3D CEPH 100-240V 1210 + WS + MONITOR | In distribution | |
| XMO 3D FLOOR 100-240V 1210 + WS + MONITOR | In distribution | |
| XMO 3D WALL 100-240V 1210 NO WS NO MONITOR | In distribution | |
| XMO 3D FLOOR 100-240V + WS + MONITOR | In distribution | |
| XMO 3D WALL 100-240V 1210 + WS + MONITOR | 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 |
| Gendex GXS-700™ intraoral sensor | Gendex Corp. | 19 |
| Genoray | Genoray Co., Ltd. | 14 |
| X-Mind trium | 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.