Owandy-RX DC
Owandy-RX DC is an X-ray unit, in particular extraoral source of X-rays, intended for intra-oral radiographic exams for diagnostic purposes related to anatomy of teeth and adjacent oral…
Owandy-RX DC is an X-ray unit, in particular extraoral source of X-rays, intended for intra-oral radiographic exams for diagnostic purposes related to anatomy of teeth and adjacent oral structures both on adult and pediatric patients, using specific x-ray detectors (chemical films, phosphor plates or digital xray sensors) that are not part of the device.
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 | Owandy Radiology, France |
|---|---|
| FDA product code | EHD |
| Device type | Unit, X-Ray, Extraoral With Timer |
| Device class | Class 2 |
| Regulation | 21 CFR 872.1800 |
| Establishment | Repacker / relabeller |
| 510(k) | K231055 |
| Record published | 2025-09-05 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Handling environment atmospheric pressure 85 to 106 KiloPascal; Handling environment humidity 25 to 75 % RH; Handling environment temperature 10 to 40 °C; Storage environment atmospheric pressure 85 to 106 KiloPascal; Storage environment humidity 25 to 75 % RH; Storage environment temperature -20 to 70 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DC OWANDY 115V,SHORT CONE,MOBILE | In distribution | |
| DC OWANDY 115V,SHORT CONE,BOTT 80 (16” – 40,64cm) | In distribution | |
| DC OWANDY 115V VET,SHORT CONE,NO BRACKET,NO WALL PLATE (CORE | In distribution | |
| DC OWANDY 115V VET,SHORT CONE,BOTT 80 (16” – 40,64cm) | In distribution | |
| DC OWANDY 115V VET,SHORT CONE,TOP 40 (16” – 40,64cm) | In distribution | |
| DC OWANDY 115V,SHORT CONE,TOP 80 (16” – 40,64cm) | In distribution | |
| DC OWANDY 115V,SHORT CONE,BOTT 110 (16” – 40,64cm) | In distribution | |
| DC OWANDY 115V,SHORT CONE,BOTT 40 (16” – 40,64cm) | In distribution | |
| DC OWANDY 115V VET,SHORT CONE,TOP 80 (16” – 40,64cm) | In distribution | |
| DC OWANDY 115V VET,SHORT CONE,TOP 110 (16” – 40,64cm) | In distribution | |
| DC OWANDY 115V VET,SHORT CONE,BOTT 110 (16” – 40,64cm) | In distribution | |
| DC OWANDY 115V,SHORT CONE,NO BRACKET,NO WALL PLATE (CORE KIT | In distribution | |
| DC OWANDY 115V,SHORT CONE,TOP 110 (16” – 40,64cm) | In distribution | |
| DC OWANDY 115V,SHORT CONE,TOP 40 (16” – 40,64cm) | In distribution | |
| DC OWANDY 115V VET,SHORT CONE,BOTT 40 (16” – 40,64cm) | In distribution | |
| DC OWANDY 115V VET,SHORT CONE,MOBILE | In distribution |
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 |
| Orthophos XG | Sirona Dental Systems Gmbh | 10 |
| Schick Elite | Sirona Dental, Inc. | 10 |
| Phot-X IIs Model 505 | Takara Belmont Corporation | 10 |
| CDR Elite | Sirona Dental, Inc. | 10 |
Showing 12 of 171. All products under Unit, X-Ray, Extraoral With Timer
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.