Midmark ClearVision Digital Sensor System
The Midmark ClearVision Digital Sensor System produces intraoral dental X-ray images for dentists and other qualified professionals. It supports examinations such as bitewing and periapical…
The Midmark ClearVision Digital Sensor System produces intraoral dental X-ray images for dentists and other qualified professionals. It supports examinations such as bitewing and periapical imaging of teeth, jaws and other oral structures. Two sensor sizes accommodate different anatomy and patient sizes.
The CMOS sensor connects directly to a computer through USB. It works with a standard intraoral X-ray source and automatically detects an exposure. After the exposure ends, the captured image transfers to imaging software on the computer.
Listed Item
Intraoral X-ray with Digital Imaging Sensor
Patient Barrier
A disposable sheath is used for each examination to help prevent cross-contamination between patients. The sensor operates without an electrical connection to the X-ray source.
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 | Midmark Corporation, United States |
|---|---|
| FDA product code | MUH |
| Device type | System, X-Ray, Extraoral Source, Digital |
| Device class | Class 2 |
| Regulation | 21 CFR 872.1800 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K112380 |
| Record published | 2016-09-23 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment humidity 5 to 85 % RH; Handling environment temperature 5 to 35 °C; Storage environment humidity 10 to 90 % RH; Storage environment temperature -40 to 70 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| XSDN-02 | In distribution | |
| XSDS-0B/L | In distribution | |
| XSDN-01 | In distribution | |
| XSDP-02 | In distribution | |
| XSDQ-02 | In distribution | |
| XSDP-01 | In distribution | |
| XSDS-02 | In distribution | |
| XSDQ-01 | In distribution | |
| XSDS-01 | In distribution | |
| XSDS-0B | 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 |
|---|---|
| K122643 | 2013-01-07 |
| K112380 | 2011-11-22 |
| K091866 | 2009-07-20 |
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.