X-Mind Trium
X-MIND trium PAN CBCT version including one PAN sensor,with control panel on the left side including one removable ceph sensor configurated for installation of ceph arm on the right
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) | K160166 |
| Record published | 2016-12-15 |
| Record revised | 2024-01-01 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment atmospheric pressure 85 to 106 KiloPascal; Handling environment humidity 25 to 75 % RH; Handling environment temperature 10 to 30 °C; Storage environment atmospheric pressure 50 to 106 KiloPascal; Storage environment humidity 25 to 75 % RH; Storage environment temperature 0 to 50 °C |
| Distribution end date | 2023-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| XMT PAN 3D L | Withdrawn | |
| XMT PAN R CEPH L 3D READY | Withdrawn | |
| XMT PAN 3D L CEPH READY R (PAN SENSOR) | Withdrawn | |
| XMT PAN L CEPH READY R | Withdrawn | |
| XMT PAN 3D L CEPH R | Withdrawn | |
| XMT PAN 3D R CEPH L | Withdrawn | |
| XMT PAN 3D L CEPH L | Withdrawn | |
| XMT PAN 3D READY L | Withdrawn | |
| XMT PAN R CEPH READY L | Withdrawn | |
| XMT PAN 3D R | Withdrawn | |
| XMT PAN 3D R CEPH R | Withdrawn | |
| XMT PAN L CEPH R 3D READY | Withdrawn |
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 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.