VistaPano S Ceph 2.0
VistaPano S Ceph 2.0 is a dental X-ray system that acquires two-dimensional panoramic and cephalometric images. The panoramic and optional cephalometric functions are combined within one…
VistaPano S Ceph 2.0 is a dental X-ray system that acquires two-dimensional panoramic and cephalometric images. The panoramic and optional cephalometric functions are combined within one imaging platform.
The system uses separate CMOS detector configurations for panoramic and cephalometric acquisition. An inverter-controlled X-ray generator supplies the exposure, while a connected computer and imaging software acquire and display the data.
Listed Item
Digital X-ray Imaging System functioning Pano/Ceph(scan type) Image Acquisition (Xmaru1501CF-PLUS / Xmaru2602CF)
Imaging Configuration
The panoramic detector is the Xmaru1501CF-PLUS; the cephalometric configuration uses the Xmaru2602CF. The generator offers tube settings from 60 to 99 kV and 4 to 16 mA. VistaPano S is the panoramic-only version of the platform. This system produces conventional two-dimensional images and does not provide cone-beam CT.
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 | Vatech Co., Ltd., South Korea |
|---|---|
| FDA product code | MUH |
| Device type | System, X-Ray, Extraoral Source, Digital |
| Device class | Class 2 |
| Regulation | 21 CFR 872.1800 |
| Establishment | Manufacturer |
| 510(k) | K240040 |
| Record published | 2024-12-13 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment atmospheric pressure 86 to 106 KiloPascal; Handling environment humidity 30 to 75 % RH; Handling environment temperature 10 to 35 °C; Storage environment atmospheric pressure 86 to 106 KiloPascal; Storage environment humidity 10 to 75 % RH; Storage environment temperature -10 to 60 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VistaPano S Ceph | 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 |
| 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 |
Showing 12 of 279. All products under System, X-Ray, Extraoral Source, Digital
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K240040 | 2024-10-25 |
| K170731 | 2017-04-04 |
| K130585 | 2013-07-15 |
| K122155 | 2012-09-04 |
| K113672 | 2012-03-27 |
| K102124 | 2010-10-22 |
| K100317 | 2010-03-24 |
| K073365 | 2008-04-08 |
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.