Portray
The Portray System is an extraoral dental X-ray system with intraoral X-ray detection for producing dental radiographs. The FDA summary describes two-dimensional imaging for diagnostic…
The Portray System is an extraoral dental X-ray system with intraoral X-ray detection for producing dental radiographs. The FDA summary describes two-dimensional imaging for diagnostic purposes and three-dimensional imaging as an adjunct to 2D image analysis.
Its components include an X-ray source array, detector holder, intraoral detector, computer and user-interface software. The system is available in a single wall-mounted configuration and produces images of teeth, jaw and other oral structures.
Listed Item
PORTRAY System – Extraoral Source X-ray System
Image Formats
The system offers tomosynthesis and synthetic 2D views; 3D is an adjunct to 2D image analysis. The detector holder and sleeve are the sole patient-contacting components.
Who Else Makes It
Concentrated in Guangxi (2), Guangdong (2), Zhejiang (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guilin Woodpecker Medical Instrument Co., Ltd. | Guilin | Guangxi | Manufacturer | 25 |
| Changzhou Sifary Medical Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 14 |
| Guangzhou Ajax Medical Equipment Co Ltd | Guangzhou | Guangdong | Manufacturer | 13 |
| Guilin Refine Medical Instrument Co., Ltd. | Guilin | Guangxi | Contract manufacturer | 7 |
| iRay Imaging Technology (Haining) Limited | Haining | Zhejiang | Contract manufacturer | 6 |
| 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 |
Record
| Listed by | Surround Medical Systems, United States |
|---|---|
| FDA product code | EHD |
| Device type | Unit, X-Ray, Extraoral With Timer |
| Device class | Class 2 |
| Regulation | 21 CFR 872.1800 |
| 510(k) | K211014 |
| Record published | 2022-12-15 |
| Record revised | 2024-10-24 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Distribution end date | 2024-10-24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DW.31.01 | Withdrawn | |
| DW.30.00 | Withdrawn | |
| DW.30.01 | Withdrawn | |
| DW.31.00 | Withdrawn | |
| DD.02.00 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Midmark | Midmark Corporation | 148 |
| Midmark Preva IntraOral Dental X-ray System | Midmark Corporation | 136 |
| Schick AE | Sirona Dental, Inc. | 53 |
| Midmark Preva 2.0 IntraOral Dental X-ray System | Midmark Corporation | 46 |
| Xios AE | Sirona Dental, Inc. | 38 |
| X-Mind unity | DE Götzen SRL | 26 |
| Midmark Vetpro IntraOral Dental X-ray System | Midmark Corporation | 26 |
| x-mind dc | DE Götzen SRL | 17 |
| Owandy-RX DC | Owandy Radiology | 16 |
| Orthophos XG | Sirona Dental Systems Gmbh | 10 |
| Schick Elite | Sirona Dental, Inc. | 10 |
| Phot-X IIs Model 505 | Takara Belmont Corporation | 10 |
Showing 12 of 171. All products under Unit, X-Ray, Extraoral With Timer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K211014 | 2021-07-28 |
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.