Portable Dental X-Ray (CS 2300p)
The CS 2300P, model NP-350E, is a handheld dental X-ray source powered by an internal rechargeable supercapacitor. Trained, qualified dentists or dental technicians use it with an intraoral…
The CS 2300P, model NP-350E, is a handheld dental X-ray source powered by an internal rechargeable supercapacitor. Trained, qualified dentists or dental technicians use it with an intraoral image receptor to obtain dental radiographs in adults and children.
The device operates at a fixed 70 kV tube voltage and 3.5 mA tube current. The operator selects exposure time, enables the unit with the lock/unlock button, then holds the trigger for the exposure.
Imaging and Charging
It can be used with film, digital intraoral sensors or phosphor plates. A beam-limiting cone and internal and external shielding are incorporated into the unit. The system includes a charging cradle and AC/DC power supply for recharging the supercapacitor.
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 | Nanoray Co., Ltd., South Korea |
|---|---|
| FDA product code | EHD |
| Device type | Unit, X-Ray, Extraoral With Timer |
| Device class | Class 2 |
| Regulation | 21 CFR 872.1800 |
| 510(k) | K201800 |
| Record published | 2021-02-18 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -10 to 60 °C; Storage environment humidity 10 to 75 % RH; Storage environment atmospheric pressure 860 to 1060 KiloPascal |
| Packaging | Inner box, outer box |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NP-350E | 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 |
|---|---|
| K201800 | 2020-12-28 |
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.