VistaPano S 2.0
VistaPano S 2.0 is a digital panoramic dental X-ray system for imaging teeth, jaws, sinuses and temporomandibular joints. This panoramic-only configuration uses the Xmaru1501CF-PLUS…
VistaPano S 2.0 is a digital panoramic dental X-ray system for imaging teeth, jaws, sinuses and temporomandibular joints. This panoramic-only configuration uses the Xmaru1501CF-PLUS detector to acquire two-dimensional diagnostic images.
An X-ray generator produces the beam, while a CMOS detector converts transmitted radiation into digital image data. The associated computer and VisionX viewing software support image processing and review.
Listed Item
Digital X-ray Imaging System functioning Pano Image Acquisition (Xmaru1501CF-PLUS)
Configuration and Users
The system is intended for adult and pediatric patients and is operated by physicians, dentists or X-ray technicians. Cephalometric imaging belongs to the separate VistaPano S Ceph configuration. The device is not intended for cone beam CT imaging.
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 | 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.