Intraskan DC Plus
INTRASKAN DC PLUS is an extraoral X-ray source used to produce intraoral dental radiographs. Its tube head is positioned outside the mouth, directing X-rays toward the intraoral receptor…
INTRASKAN DC PLUS is an extraoral X-ray source used to produce intraoral dental radiographs. Its tube head is positioned outside the mouth, directing X-rays toward the intraoral receptor for diagnostic imaging.
The system includes a base, tube housing with beam limiter, control console and articulated positioning arms. Separate microprocessors handle control and the user interface, with feedback circuits regulating X-ray output.
Listed Item
Intraskan DC Plus with 15″ Support tube is High Frequency Extra oral X-Ray source to be used for Intra oral X-Ray in Dental Radiography for diagnostic purpose.
Exposure Settings
The console provides selectable tube voltage from 60 to 70 kVp and tube currents of 4, 5, 6, 7 or 8 mA. Exposure time ranges from 0.01 to 3.50 seconds. Wall, chair-mounted and floor-standing configurations are available.
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 | Skanray Technologies Limited, India |
|---|---|
| FDA product code | EHD |
| Device type | Unit, X-Ray, Extraoral With Timer |
| Device class | Class 2 |
| Regulation | 21 CFR 872.1800 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| 510(k) | K170967 |
| Record published | 2019-09-26 |
| Record revised | 2022-01-19 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 303-000134-24 | In distribution | |
| 303-000134-25 | In distribution | |
| 303-000134-26 | In distribution | |
| 303-000134-27 | 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 |
| 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 |
|---|---|
| K170967 | 2017-06-08 |
| K111330 | 2011-05-27 |
| K103579 | 2011-03-18 |
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.